The decision to replace your unit is not an easy one. You can not casually decide to do this, but need to consult your physician. Studies reveal a 2-7% death rate as a result of surgery and complications from surgery related to defibrilaltors. Keep in mind, those statistics are not just related to the defect Guidant units. Also keep in mind that the population of patients undergoing this surgery are often otherwise compromised, of old age, and/or in poor health.
Nevertheless, the situation with these Guidant defbirillators is serious enough that the FDA has issued nationwide notifications to doctors. The FDA wants to make certain that all patients who may be affected by this problem are notified. They seek to have these patients notify their physicians and obtain appropriate medical advice. There are more than 150,000 devices in quiestion in the USA alone.
Even Guidant has conceded that there needs to be a recall of certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators. Many models of these Guidant devices are now being recalled. (Note: In a related matter, a number of Medtronic devices are being recalled because of a problem with their batteries).
The evidence that these units need to be replaced is overwhelming. In fact, Guidant has already admitted that it knows of at least 45 cases, according to filings with the FDA and recent disclosures, the products have failed. There are also reports of at least two wrongful death cases filed for deaths attributed to these defects.
There are a number of different defects, depending on which unit you have. Some of the devices develop an internal short circuit without warning, resulting in failure to deliver a shock when needed. The device is supposed to deliver a shock when it senses that the heart has entered into a rhythm called "ventricular tachycardia." Still other devices have a problem related to the magnetic switch, others have problems with their programming (which apparently now can not be fixed by "reprogramming"). There are also complaints about units whose lead wires crack. (However the lead wires are not the subject of the recent recall).
As of July 21, 2005, the Guidant units which should be considered for replacement are:
- Contak Renewal Model H135
- Contak Renewal Model H155 CRT-D
- Contak Renewal 3
- Contak Renewal 4
- Contak Renewal AVT
- Ventak Prizm 2 DR
- Ventak Prizm AVT
- Vitality AVT
- Renewal 3 AVT
- Renewal 4 AVT
- Renewal RF
- Pulsar Max
- Pulsar
- Discovery
- Meridian
- Pulsar Max II
- Discovery II
- Contak TR
- Virtus Plus II
- Intelis II
And the Medtronic units that are in question are:
- Model 7230 Marquis VR
- Model 7274 Marquis DR
- Model 7232 Maximo VR
- Model 7278 Maximo DR
- Model 7277 InSync Marquis
- Model 7289 InSync II Marquis
- Model 7279 InSync III Marquis
- Model 7285 InSync III Protect
Regardless of whether you decide to have your unit replaced, what is clear is that both Guidant and Medtronic knew of the defects in their defibrillators, yet continued to sell them with these defects. Thus, long before they told the public, and long before they told the medical community -- while defective inventory continued to be sold for implantation in thousands of patients in the United States and worldwide -- Guidant and Medtronic knew what was wrong.
Thus, while the "FDA's first priority is patient safety," as said by Daniel Schultz, MD, Director of FDA's Center for Devices and Radiological Health, not the same can be said for Guidant and Medtronic, judging from the actions of these companies.
