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Guidant Initiates Voluntary Physician Advisory on Certain Pacemakers

Sep 22, 2005 | BUSINESS WIRE

Guidant Corporation said today that it is informing physicians about two separate failure modes, each occurring at a low rate, being monitored within the INSIGNIA(R) and NEXUS(R) families of Guidant implantable pacemakers. Physicians should use this information to decide how best to treat their patients.

These failure modes may result in one or more of the following device behaviors:

Intermittent or permanent loss of pacing output without warning

Intermittent or permanent loss of telemetry

 Appearance of a reset warning message upon interrogation

The clinical behaviors associated with these failure modes can result in serious health complications. There have been no reported deaths resulting from these failure modes. Loss of pacing output associated with these failure modes has resulted in syncope as well as presyncope requiring hospitalization.

For the first failure mode, as of September 6, 2005, Guidant has confirmed thirty-six (36) failures out of 49,500 implanted devices (0.073%). Seven (7) of these devices exhibited no output during the implant procedures. For devices successfully implanted, the majority of failures occurred early in life, with a mean implant time of seven (7) months. This failure mode demonstrates a failure rate that decreases with implant time. No failures have been reported beyond twenty-two (22) months of service. Guidant has received three (3) reports of syncope, and six (6) reports of bradycardia or heart block associated with this failure mode which required emergency hospitalization. One device was determined to have failed briefly and resumed functioning with no indication to the physician detectable during routine follow-up.

Guidant's modeling based on field experience and statistical analysis, predicts the failure rate for the active device population of 41,000 to be between 0.017% to 0.037% over the remaining device lifetime, or approximately seven (7) to fifteen (15) additional failures. An estimated 24,000 are active in the United States. Root cause has been identified as foreign material within a crystal timing component. The supplier of the crystal timing component used in this subset has eliminated foreign material within the crystal chamber, and no such failures have been observed in any devices shipped after March 12, 2004.

The United States Food and Drug Administration (FDA) has determined this communication action to be a recall. Physicians should consider the projected low and declining failure rate in addition to the unique needs of individual patients in their medical decisions regarding patient management. Guidant recommends normal device monitoring, as per device labeling. As always, Guidant advises patients to seek medical attention immediately if they experience syncope or lightheadedness.

As of September 6, 2005, sixteen (16) failures associated with a second failure mode have been confirmed out of 341,000 INSIGNIA and NEXUS devices distributed worldwide (0.0047%). For all sixteen devices, a "no output" condition was exhibited at the implant procedure or pre-implant testing. Guidant has received one (1) report of a pacemaker-dependent patient experiencing syncope and resuscitated cardiac arrest that occurred in association with loss of pacing output during an elective pulse generator replacement procedure. Root cause analysis is ongoing; a specific root cause for this observation has not yet been determined. An estimated 145,000 of these devices are active in the United States.

The United States Food and Drug Administration (FDA) may determine this communication action to be a recall. Guidant recommends verifying pacemaker operation in the packaging prior to the implant procedure. Devices exhibiting intermittent or permanent loss of output and/or telemetry should not be implanted. Physicians should consider both the very low occurrence rate and that no failures have been observed after successful confirmation of pacing at implant, in addition to the unique needs of individual patients, in their medical decisions regarding patient management.

The following model numbers are affected by this communication(a):

         Guidant Pacemakers           Guidant  Intermedics Pacemakers
Device Family      Model Numbers     Device Family   Model Numbers
INSIGNIA Entra SSI 0484, 0485        NEXUS Entra SSI 1325, 1326
INSIGNIA Entra DDD 0985, 0986        NEXUS Entra DDD 1425, 1426
INSIGNIA Entra SR  1195, 1198        NEXUS Entra SR  1395, 1398
INSIGNIA Entra DR  1294, 1295, 1296  NEXUS Entra DR  1466, 1494, 1495
INSIGNIA Ultra SR  1190              NEXUS Ultra SR  1390
INSIGNIA Ultra DR  1290, 1291        NEXUS Ultra DR  1490, 1491
INSIGNIA Plus SR   1194              NEXUS Plus SR   1394
INSIGNIA Plus DR   1297, 1298        NEXUS Plus DR   1467, 1468
INSIGNIA AVT SSI   482               NEXUS AVT SSI   1328
INSIGNIA AVT VDD   882               NEXUS AVT VDD   1428
INSIGNIA AVT DDD   982               NEXUS AVT DDD   1432
INSIGNIA AVT SR    1192              NEXUS AVT SR    1392
INSIGNIA AVT DR    1292              NEXUS AVT DR    1492

(a) Not all models are available in all geographies.

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