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Guidant INSIGNIA and NEXUS Implantable Pacemakers

2005 Recall
Guidant Corporation on September 22, 2005 informed physicians about two isolated failure modes, for the INSIGNIA and NEXUS families of Guidant implantable pacemakers. The failure modes can result in one or more of the following device behaviors: a) Irregular or permanent loss of telemetry; b) Appearance of a reset warning message upon interrogation; and c) Sporadic or permanent loss of pacing output without warning. The FDA has determined this communication action to be a recall.

The clinical behaviors connected with these failure modes can cause serious health complications. Loss of pacing output related to 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 36 failures out of 49,500 implanted devices (0.073%). Seven 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 months.

Guidant has received three reports of syncope, and six 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 to fifteen additional failures. An estimated 24,000 are active in the United States. 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.

The following model numbers are affected:

Guidant Pacemakers
INSIGNIA Entra SSI 0484, 0485; DDD 0985, 0986; SR 1195, 1198; DR 1294, 1295, 1296; Ultra SR 1190; DR 1290, 1291; Plus SR 1194 INSIGNIA Plus DR 1297, 1298 NEXUS Plus DR 1467, 1468; AVT SSI 482 NEXUS AVT SSI 1328; AVT VDD 882; AVT DDD 982; AVT SR 1192; AVT DR 1292.

Guidant Intermedics Pacemakers
NEXUS Entra SSI 1325, 1326; DDD 1425, 1426; SR 1395, 1398; DR 1466, 1494, 1495; Ultra SR 1390; DR 1490, 1491; Plus SR 1394; DR 1467, 1468, AVT SSI 1328; VDD 1428, DDD 1432, SR 1392, DR 1492.

2006 Recall
On June 26, 2005, Guidant in conjunction with the FDA notified patients and medical professional that the INSIGNIA and NEXUS implantable pacemakers and the Guidant CONTAK RENEWAL TR/TR2 Cardiac Resynchronization Therapy Pacemakers have been linked to five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Individuals with these pacemakers may suffer irregular or permanent loss of output, telemetry, and or premature battery depletion.

If you or a loved one suffered injuries from a Guidant Pacemaker, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.