Dear Doctor Letter (June 17, 2005 Re VENTAK PRIZM 2 DR, Model 1861):

Dear Doctor Letter (June 17, 2005 Re VENTAK PRIZM 2 DR, Model 1861):
In February 2002, Guidant's Cardiac Rhythm Management Quality System
identified a problem in PRIZM 2 DR ICDs. Subsequent laboratory analysis of
returned products revealed that deterioration in a wire insulator within the lead
connector block, in conjunction with other factors, resulted in an electrical short.
Resultant circuit damage caused permanent loss of shock therapy and pacing.
Manufacturing changes intended to prevent this failure were made on April 16,
2002 and on November 13, 2002.

There have been 28 reports of this failure worldwide, in 26,000 devices built
prior to the April 2002 change. This includes an event reported in March of 2005
in which a device was returned after a patient death.

To date, no such failures have been observed in the devices built after the April
2002 change (including the approximately 11,000 devices built after the April
2002 change and before the November 2002 change). Approximately 13,900
devices built before the April 2002 change remain in service in the United States.
After making the manufacturing changes, Guidant sold product manufactured
before the April 2002 change. At that time, data did not show an unusual failure
rate and Guidant believed the device to be reliable.

Guidant is providing physicians with a list of patients implanted with PRIZM 2
DR ICDs made before November 2002 change and will clearly denote those
devices manufactured between the April 2002 and November 2002 changes.
Death associated with device failures may be under-reported, since ICDs are not
routinely evaluated postmortem.

Guidant concluded, based on bench testing, that there is no way to predict
whether any particular device will in fact fail.

In addition to normal follow-up at three-month intervals, patients with
identified PRIZM 2 DR ICDs should consult with their follow-up clinic after
receiving a defibrillation shock.

Guidant does not recommend replacement of these devices prior to the
appearance of normal elective replacement indicators (ERI). Early replacement
of pre-April 2002 PRIZM 2 DR devices may not provide the patie nt with a lower
risk, relative to the risks of an invasive procedure. As always, physicians should
make the final determination on a case-by-case basis regarding whether device
replacement is warranted based upon the individual patient's medical history.
However, if you decide to explant a device, Guidant will provide a replacement
device at no charge, pursuant to Guidant's supplemental replacement policy, and
provide unreimbursed medical expenses to patients for documented out-of-pocket
expenses up to $2,500, provided the device being explanted was manufactured
prior to November 13, 2002 and has not reached its ERI.