FDA Updates Consumers on Guidant Corporations Implantable Defibrillators
July 1, 2005 07:00

These devices are subject to a component failure that in rare cases may limit available therapy. A magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the devices ability to treat ventricular or atrial tachyarrhythmias (abnormally fast heart rhythms) and also accelerates battery depletion. Four occurrences have been confirmed out of approximately 46,000 devices; a fifth occurrence is suspected but cannot be confirmed. In the four confirmed cases, patients and/or physicians were alerted to the condition by audible device tones signaling that the magnetic switch was closed. Based on this information, it is important that patients who hear tones from their device immediately contact their physician or go to the hospital emergency room. (Read this Article)

FUNCTION AND PURPOSE

An Implantable Cardioverter Defibrillator (ICD) is a device that is implanted in the chest to
monitor for and, if necessary, correct episodes of abnormal heart rhythm (ARRYTHMIA).
ICDs can generate (1) a series of precisely timed low-intensity electrical pulses to reset the heart
to normal rhythm when the heartbeat becomes faster than normal (VENTRICULAR TACHYCARDIA), and
(2) electric shocks that may feel like a sudden kick in the chest to stop potentially fatal quivering of the
heart (VENTRICULAR FIBRILLATION). In addition, the ICD may be programmed to work as a pacemaker
and send small electrical signals to pace the heart whenever it detects an abnormally low heartbeat
(BRADYCARDIA).

An ICD may be recommended for patients who have experienced:

1. Previous heart attacks
   
2. History of ventricular tachycardia (VT)
   
3. History of ventricular fibrillation (VF)
   
4. Coronary artery disease
   
5. Cardiac arrest
   
6. Heart failure
   
7. Persistent atrial fibrillation

However, not every person needs an ICD. ICDs are generally not necessary when an
ARRHYTHMIA:

1. is an isolated occurrence with no underlying disease
   
2. is caused by an electrolyte imbalance or drug overdose
   
3. occurred within the first 48 hours of a heart attack
   

ICDs are among the fastest-growing group of medical devices; in the year 2005 alone, more than
200,000 patients are expected to have one implanted. In 2001, Vice President Dick Cheney received an
ICD made by Medtronic. An ICD can cost up to $25,000 for the device itself and uncomplicated hospital
and doctor costs can run another $15,000 to $25,000.

The ICD consists of three parts:GENERATOR: located in the main box of the ICD, battery powered, 2 incheswide, 3 ounces; responsible for generating the electric shockLEADS: silicon/polyurethane insulated platinum wires; carry theelectric shock from the generator... (Read this Article)

POTENTIAL RISKS WITH ICDs

Serious complications from the surgery (<1% of cases):


1. Death

2. Heart attack

3. Stroke

4. Electrical storm2

5. Puncture of lung or heart muscle

6. Blood clots

7. Torn blood vessel

8. Severe bruising or bleeding

9. Air intrusion between lungs and the chest wall

Other less serious complications:

10. Chest pain
11. Palpitations

12. Fainting

13. Shortness of breath, prolonged hiccupping, difficulty breathing

14. Redness, warmth, tenderness, or swelling of the incision site

15. Drainage of liquid from the incision site along with fever

The risk of having one of these complications is increased with:

• Advanced age
  
• Obesity (BMI 30 or greater)
  
• Severe lung disease
  
• Use of various medications

June 17, 2005
Subject: Important Safety Information on VENTAK PRIZM AVT, VITALITY AVT and CONTAK RENEWAL AVT implantable cardiac defibrillators...

Dear Health Care Professional,

This letter is intended to inform you of important safety information regarding all serial numbers of VENTAK PRIZM AVT, VITALITY AVT, and CONTAK RENEWAL AVT. Our records indicate that you have implanted or are monitoring patients that have these devices. This letter is intended to fully advise physicians and their patients about the problem and to limit adverse events.

Guidant's Cardiac Rhythm Management Quality System has determined that the atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional "latching" that limits available therapy. Engineering analysis has determined that latching can only occur when storing tachy detection/therapy episode information to affected memory. Two occurrences have been confirmed out of approximately 20,950 devices implanted to date; none have resulted in patient injury beyond device replacement. A software solution is expected by the end of this year.

Clinical Implications
Latching of AVT devices will suspend detection and treatment of atrial and ventricular arrhythmias. Telemetry and programming are not available. Brady pacing may continue, but will not be programmable and may not match programmed settings. In a latched state, battery usage may increase, but battery status indicators will not be available. In the event that latching occurs during delivery of ATP therapy, ATP therapy delivery could continue independent of patient need. Device replacement is required if latching occurs.

Guidant has developed a predictive engineering model to generate rate-of-occurrence probabilities described in Table 1. This table is based on Guidant's understanding of root cause, in conjunction with bench testing of returned product. If no programming actions are taken, Guidant's model predicts that one additional latching event would occur worldwide before implementation of a software solution, which is expected by year-end.

Recommendations
Currently, programming options are available to further diminish the already very low probability of even one more latching event. Guidant recommends the following actions at the next regularly scheduled office visit:

* Verify normal device function using routine clinical follow-up procedures
* Program Atrial Tachy Episode Data Storage to 0% (Option B in Table 1)
* Review the rate of occurrence estimates in Table 1 to evaluate the additional risk reduction benefit of temporarily programming ATP therapy OFF (Option C in Table 1)

RECALL 50,000 DEFECTIVE ICDs MANUFACTURED BY GUIDANT CORP

On June 17, 2005, the FDA issued a nationwide notification or RECALL of certain Guidant
implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices were
reported to develop an "internal short circuit without warning", resulting in failure to deliver a shock
when needed.

The devices affected by the June 17, 2005 RECALL are 29,000 ICDs (20,600 implanted in the
USA). As part of the recall, Guidant said it would provide "free replacements" but no further
compensation for the people implanted with the following devices:

• VENTAK PRIZM 2 DR (Model 1861) manufactured on or before April 16, 2004
  
• CONTAK RENEWAL (Model H135) manufactured on or before August 26, 2004
  
• CONTAK RENEWAL (Model H155) manufactured on or before August 26, 2004

In addition, Guidant recently informed the FDA that it was recalling 21,000 ICDs (18,000
implanted in the USA) due to memory errors which may affect device performance. For these ICDs,
Guidant is recommending a programming change and will not pay for either replacement or other
compensation typically available to tort victims such as loss of earnings, medical costs, and pain and
suffering damages. The devices covered by the recall are as follows:

• VENTAK PRIZM AVT (Model 1900)
  
• VITALITY AVT (Model A135, A155)
  
• CONTAK RENEWAL 3 AVT (Model H150, H155)
  
• CONTAK RENEWAL 3 AVT HE (Model M157, M159)
  
• CONTAK RENEWAL 4 AVT (Model H170, H175)
  
• CONTAK RENEWAL 4 AVT HE (Model H177, H179)

On June 24, 2005, Guidant issued yet another press release which the FDA may classify as
another RECALL. Current reports indicate that 46,000 ICDs are implicated by this special advisory. In its
press release, Guidant admits that other ICDs have a magnetic switch in some devices that may
become stuck in the closed position, which in some cases inhibits the device's ability to treat ventricular
or atrial tachyarrhythmias and can accelerate battery depletion. Guidant has not advised that they will
offer any compensation for the devices impacted by this press release, which are as follows:

• 
  CONTAK RENEWAL 3 (Model H170, H173, H175)
• CONTAK RENEWAL 3 HE (Model H177, H179)
• RENEWAL 3 AVT (Model H150, H155)
• RENEWAL 3 AVT HE (Model M157, M159)
• CONTAK RENEWAL 4 (Model H190, H195)
• CONTAK RENEWAL 4 HE (Model H197, H199)
• RENEWAL 4 AVT (Model H170, H175)

In response to these recalls/warnings letters involving nearly 100,000 devices, the FDA has
advised patients to take the following steps:

• Contact your doctor to determine if you have an affected ICD
  
• Contact your doctor if you feel an electrical shock from your device
  
• Contact your doctor or go to the nearest emergency room if you hear an
  audible beeping from your ICD.
  

Health Canada has announced that it will soon send a letter to doctors who prescribe another
Guidant ICD, the PRIZM 2DR device of which 496 are known to have been sold in Canada and are also
defective. The health ministry is still talking to the company to determine which of the other models, if
any, have been sold in Canada.

GUIDANT HAS FAILED TO WARN DOCTORS AND PATIENTS ABOUT THE DEFECTS ASSOCIATED WITH
ITS ICDS FOR YEARS

Guidant has admitted to knowing of malfunctions in its ICDs for 3 years now and continued to
sell the defective ICDS and allowed them to be surgically implanted in patients - Knowing patients were
at risks for severe failures that could obviously lead to complications including death.

Guidant has admitted that it became aware of the problem in 2002 and made a manufacturing
change but did not say what happened with the original devices. People familiar with the matter now
say the company continued to sell the original device, and allowed it to go into patients, knowing that
two devices had malfunctioned. Nevertheless, Guidant concluded in 2002, and still maintains, that the
malfunction, in which the device short-circuited and failed to administer electrical therapy to patients,
was so rare that it did not warrant a recall of the product. They didn't specify the number of devices
installed in patients after the malfunction was found, but Guidant has estimated that a total of about
24,000 are still implanted in patients' chests.

Guidant came under fire in the spring of 2005 after The New York Times reported that it failed to
alert physicians and heart patients about a potential problem with the VENTAK PRIZM DR model
defibrillator. A month later, Guidant notified doctors that a small number of defibrillators had failed
because of an electrical flaw. It also said that it had fixed the flaw in devices made after mid-2002.

In interviews in May 2005, a top Guidant executive, Dr. Joseph M. Smith, said that the companyhad not seen a compelling reason to issue an alert to physicians about the defibrillators because their failurerate was very low and replacing them might pose greater... (Read this Article)

Despite admitting serious problems with its ICDs, Guidant will not publicly advocate their
removal, since to do so could expose itself to significantly liability. This is in direct contrast to steps
taken by Guidant ICD's competitor, Medtronic Inc. of Minneapolis, who also found a manufacturing flaw
in one of its Marquis defibrillators. The defect in the Marquis defibrillator, the company found, could
mean that the battery would become depleted too quickly in as many as 1.5% of the 87,000 devices
made. In February of 2005, Medtronic sent out a notification to doctors about the defect and has
received a huge response from doctors. In the U.S., 11,000 of the devices have been surgically removed
and replaced with a different device, and 2,000 more such removals have taken place overseas.

Unlike Medtronic, Guidant has said it does not recommend early replacement of these devices.
Patients with defective units were merely advised to consult with their physicians, particularly if they've
sustained a recent defibrillation shock.

Guidant has worked with the Food and Drug Administration (FDA) on this
communication and Guidant will continue working with the FDA on this issue,
including any subsequent communication that may be helpful for patients or
physicians.

Dear Doctor Letter (June 17, 2005 Re VENTAK PRIZM 2 DR, Model 1861):In February 2002, Guidant's Cardiac Rhythm Management Quality Systemidentified a problem in PRIZM 2 DR ICDs. Subsequent laboratory analysis ofreturned products revealed that deterioration in... (Read this Article)

Dear Doctor Letter (June 17, 2005 Re CONTAK RENEWAL, Models H135, H155):Laboratory analysis is revealed that deterioration in a wire insulator within thelead connector block, in conjunction with other factors, could cause a shortcircuit and loss of device function... (Read this Article)

Guidant's Cardiac Rhythm Management Quality System has determined that theatrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D productfamilies are subject to a condition in which a random memory error causesfunctional latching that limits available... (Read this Article)

Re CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF):This letter is intended to advise physicians and their patients about the problemand to limit adverse events. FDA may consider this action as a recall. At thistime, we are in the very early stages... (Read this Article)

JOHNSON & JOHNSON'S ACQUISITION OF GUIDANT CORPORATION

In April 2005, Guidant shareholders approved a $25.4 billion acquisition by Johnson and
Johnson. Following the RECALL, J&J said that it continues to work toward completing the acquisition in
the third-quarter, adding, nonetheless, the events reported by Guidant are serious matters, and Johnson
and Johnson is engaged in discussions with Guidant to help the company understand the issues.
Guidant and Cordis Corporation, a Johnson & Johnson Company, will become part of a newly created
cardiovascular device unit within Johnson & Johnson. The newly created franchise will be named
Guidant.

Date: July 14, 2005This is to provide clinicians with current information and guidance concerning malfunctions occurring with Guidant's PRIZM 2 and CONTAK RENEWAL implantable cardioverter defibrillator (ICD) devices, which were the subjects of a Class I recall... (Read this Article)

Date: Mon, 18 Jul 2005 13:14:06 -0400

From: CDER MEDWATCH LISTSERV

Subject: FDA MedWatch - Guidant VENTAK PRIZMR 2 DR and CONTAK RENEWALR Imp lantable Cardioverter Defibrillators:Preliminary Public Health Notificati on and advice for patients



MedWatch - The FDA Safety Information and Adverse Event Reporting Program



FDA issued a Preliminary Public Health Notification and Advice for Patients for Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators to provide clinicians with current information and guidance concerning malfunctions occurring with these devices, which were the subjects of a Class I recall announced by FDA on July 1, 2005. The malfunction that is the subject of the recall causes damage to the device's circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. The affected devices are:



VENTAK PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002 CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004 CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004



Read the complete MedWatch 2005 Safety summmary, including links to the Notification, Advice for Patients and previous July 1 MedWatch alert, at: http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Guidant2

Guidant Corp. on Monday warned physicians that replacements might be needed for nine pacemaker models made between 1997 and 2000, of which some 28,000 remain implanted in patients worldwide.

The Indianapolis-based company, which last month recalled almost 109,000 defibrillators, released a warning that says a sealing component in the pacemakers has degraded in some cases, resulting in higher-than-normal moisture in the devices and possible malfunction.

The company said about 78,000 of the devices were distributed, with about 18,000 of them remaining in U.S. patients.

Advice for Patients with VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators PRIZM 2 DR, Model 1861, manufactured before April 16, 2002, CONTAK RENEWAL, Model H135, manufactured before August 26, 2004, CONTAK RENEWAL 2, Model H155, manufactured before August 26, 2004 (Read this Article)

Date: Tue, 19 Jul 2005 13:31:50 -0400

From: CDER MEDWATCH LISTSERV

Subject: FDA MedWatch - Guidant Cardiac Pacemakers: New safety informatio n for certain models of cardiac pacemakers manufactured between 1997 and 2000

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Guidant notified physicians and patients of new safety information for certain models of cardiac pacemakers manufactured between November 25, 1997 and October 26, 2000. A hermetic sealing component used in these devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life. The clinical behaviors associated with this failure mode can result in serious health complications. Guidant has confirmed twenty reports of loss of pacing output associated with this failure mode, including five patients experiencing syncope. Loss of pacing output has also been associated with reports of presyncope requiring hospitalization. Guidant has received two reports of sustained Maximum Sensor Rate ("MSR") pacing in which heart failure may have developed in association with sustained high rate pacing. Physicians should consider the unique needs of individual patients and the specific technical recommendations set forth in the July 18, 2005 physician communication. Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients and advises patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.

Read the complete MedWatch 2005 Safety summary, including a link to the firm press release and the Guidant physician communication, at:

http://www.fda.gov/medwatch/safety/2005/safety05.htm#Guidant3

Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Certain PacemakersContact:Steven Tragash317-971-2031FOR IMMEDIATE RELEASE -- Indianapolis, IN -- July 18, 2005 -- Guidant Corporation (NYSE:GDT)... (Read this Article)

Only the following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000.

• PULSAR MAX Models 1170, 1171, 1270
  
• PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
  
• DISCOVERY Models 1174, 1175, 1273, 1274, 1275
  
• MERIDIAN Models 0476, 0976, 1176, 1276
  
• PULSAR MAX II Models 1180, 1181, 1280
  
• DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
  
• CONTAK TR Model 1241
  
• VIRTUS PLUS II* Models 1380, 1480
  
• INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

If you know your device's model and serial number and want to find out if it is affected by the leakage problem, you can check www.guidant.com/webapp/emarketing/lookup.jsp or contact Guidant Technical Services at 1-866-GUIDANT (1-866-484-3268).

FOR IMMEDIATE RELEASEP05-46July 22, 2005 Media Inquiries:Julie Zawisza, 301-827-6242Consumer Inquiries:888-INFO-FDA FDA Announces Guidant's Class I Pacemaker Recall The U.S. Food and Drug Administration (FDA) is notifying health care providers and patients... (Read this Article)

Date: Fri, 29 Jul 2005 15:20:46 -0400
From: CDER MEDWATCH LISTSERV
Subject: FDA MedWatch - Guidant Implantable Defibrillators VENTAK PRIZM, V ITALITY, and CONTAK RENEWAL AVT models: updated safety instructions

MedWatch - The FDA Safety Information and Adverse Event Reporting Program: Guidant notified healthcare professionals in an update letter issued July 22 that one of the safety recommendations made to physicians on June 17 regarding its VENTAK PRIZM, VITALITY, and CONTAK RENEWAL AVT implantable cardioverter defibrillators (ICDs) may significantly increase the risk to patients. Physicians are advised to schedule follow-up visits as soon as possible for patients with devices reprogrammed as per original instructions and for all patients with Atrial Episode Data Storage programmed to less than 20%.

Read the complete MedWatch 2005 Safety summary, including links to the Dear Healthcare Professional letter and previous MedWatch safety information on these products, at:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Guidant

Previous safety information regarding all serial numbers of VENTAK PRIZM AVT, VITALITY AVT, and CONTAK RENEWAL AVT. Our records indicate that you have implanted or are monitoring patients that have these devices. Guidant is revising its original recommendations set forth in the June 17, 2005 letter because new information indicates that one of the original recommendations can increase the risk of a latching event. The FDA may consider this action as a recall.

June 17, 2005 communication to physicians, Guidant has determined that the atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which functional "latching" limits available therapy. At that time, two occurrences had been confirmed out of approximately 20,950 devices implanted to date.

July 11, 2005, a third AVT latching event was reported in the United States. Guidant immediately began analysis and has determined that this event occurred despite Atrial Episode Data Storage being programmed to 0%. This resulted in a latched state of continuous pacing at approximately 120 pulses per minute. This third event, similar to the first two events, resulted in no apparent patient injury beyond device replacement. Additional events, including a possible injury, are being evaluated.

Latching of AVT devices will suspend detection and treatment of atrial and ventricular arrhythmias. Telemetry, programming and magnet response are not available. Brady pacing may continue, but will not be programmable and may not reflect programmed settings. In a latched state, battery usage may increase, but battery status indicators will not be available. In the event that latching occurs during delivery of ATP therapy, ventricular or atrial ATP therapy delivery could continue independent of patient need. Device replacement is required if latching occurs.

Based on study of the recent third event, Guidant has determined that one of our original recommendations programming Atrial Tachy Episode Data Storage to 0% can cause latching in a subset of AVT devices that have previously stored atrial episode data. Guidant has determined that this newly observed latching pathway can have a significantly higher probability of occurrence (estimated at 0.086% per month) for devices that have previously stored atrial episode data. For this reason, our recommendations have been altered as follows:

Schedule a patient follow-up visit As soon as possible for patients reprogrammed to 0% according to our June 17th recommendation, or any patient with Atrial Episode Data Storage programmed to less than 20%Per normal scheduling if Atrial Episode Data Storage... (Read this Article)

Devices Impacted:

Only atrial therapy AVT subgroups of Guidant ICD and CRT-D product families are impacted by this anomaly. This issue does not impact standard ICDs and CRT-Ds. Table 2. AVT Models Impacted Device Family Model Numbers VENTAK PRIZM AVT 1900 VITALITY AVT A135, A155 CONTAK RENEWAL 3 AVT* M150, M155 CONTAK RENEWAL 3 AVT HE* M157, M159 CONTAK RENEWAL 4 AVT* M170, M175 CONTAK RENEWAL 4 AVT HE* M177, M179 *Under clinical investigation in some geographies. Updated device lists specific to your clinic will be provided.

While programming options discussed above will significantly reduce the risks of functional latching in a PRIZM AVT, estimates of normal service life for remaining PRIZM AVTs indicate that few will be in service by the time a software solution can be developed and approved. Accordingly, no software update will be developed for PRIZM AVT.

Further Information We recognize the impact of this communication on both you and your patients, and want to reassure you that patient safety remains Guidant's primary concern. As always, if you have any questions regarding this communication, please contact your local Guidant representative or Guidant Technical Services at 1-800-CARDIAC (1-800-227-3422).