Home/Recalls/FDA Device/2006/Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. Th

FDA Device December 27, 2006

Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. Th

Hazard

A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.

What You Should Do

Remedy

Important Medical Device Safety Information & Corrective Action , dated 09/22/05 was sent to all affected physicians. This letter explained the failure mode, what devices are affected and gave recommendations. A press release was issued on 09/22/05.

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Products

Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedi

Brand: Guidant Corporation
UPC: Affected devices may be found in the following serial number ranges. INSIGNIA Entra SSI (model 0484) serial no. 100879 - 115237; (model 0485) serial no. 100088 - 100104; NEXUS Entra SSI (model 1326) serial no. 100122 - 100175. INSIGNIA Entra DDD (model 0985) serial no. 100059 - 100089; (model 0986) serial no. 100600 - 104439; NEXUS Entra DDD (model 1426) serial no. 100032 - 100091. INSIGNIA Entra SR (model 1195) serial no. 100739 - 101623; (model 1198) serial no. 102498 - 117468; NEXUS Entra SR (model 1398) serial no. 100067 - 100120. INSIGNIA Entra DR (model 1294) serial no. 101132 - 107445 & 292190; (model 1295) serial no. 100503 - 102668; (model 1296) serial no. 101519 - 153064; NEXUS Entra DR (model 1494) serial no. 100028 & 100029.

Units Affected

15,232

Hazard

What You Should Do

Products

Units Affected

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