Dear Doctor Letter (June 17, 2005 Re CONTAK RENEWAL, Models H135, H155):

Dear Doctor Letter (June 17, 2005 Re CONTAK RENEWAL, Models H135, H155):
Laboratory analysis is revealed that deterioration in a wire insulator within the
lead connector block, in conjunction with other factors, could cause a short
circuit and loss of device function due to diversion of therapy energy away from
the heart and into device circuitry. Fifteen (15) reports of this failure mode have
been confirmed from approximately 16,000 devices implanted worldwide. This
includes an event in which a device was returned after a patient death on May
30, 2005.

Laboratory analysis has determined that deterioration in a wire insulator
surrounding a high voltage wire within the lead connector block can, in
conjunction with other factors, allow shorting of energy to the active titanium
case during shock delivery.

Bench testing shows that only about 20% of the intended shock energy will be
delivered to the heart when this type of short occurs. If sufficient shock energy is
diverted to internal circuitry, it may render the device inoperative, preventing
telemetry and delivery of additional shock therapy or pacing therapy.
In all cases, device replacement is required if this short circuit occurs.
Guidant concluded, based on bench testing, that there is no means of predicting
whether any particular device will fail.

Guidant recommends the following:


Continue with normal follow-up patient visits at three-month intervals.
Advise patients to visit their follow-up clinic or doctor for device evaluation as
soon as possible after a shock.

If a patient has not recently received a high-voltage therapy, you may choose to
perform a commanded shock to confirm integrity of the high voltage delivery
circuit.

During every patient visit, verify normal device function using routine clinical
follow-up procedures.

If patients hear a post-shock beeping, they should go to their follow-up clinic
or hospital emergency room immediately.

Fifteen (15) reports of occurrences of this issue have been confirmed out of
approximately 16, 000 devices implanted, which equates to a current report rate
of 0.094%. Guidant�s modeling based on field experience and statistical lifetable
analysis indicates that the rate of reported failures may increase to between
0.20% and 0.59% over the device family lifetime. A greater increase in failure
rate is possible; however, Guidant also recognizes that the actual event rate may
be greater than the rate of reported failures. Deaths with the device failures may
be under-reported, since CRT-Ds are not routinely evaluated postmortem. It is
estimated that 11, 900 devices from this population remain in service worldwide.
Approximately 6,700 of these are in the United States.

Guidant has implemented design and manufacturing corrective actions to
address internal shorting within the device header. No devices manufactured
after August 26, 2004 have exhibited this failure.

If a decision is made to explant a CONTAK RENEWAL (Model H135) or
CONTAK RENEWAL 2 (Model H155) due to this issue, Guidant will provide a
replacement device at no charge, and provide unreimbursed medical expenses to
patients for documented out-of-pocket expenses up to $2500, provided the device
being explanted was manufactured on or before August 26, 2004 and has not
reached its normal elective replacement indicator.