Guidant Insignia and Nexus Pacemakers

Information on the Warning from Guidant

 
Guidant Warning

Guidant Corp. warned physicians about problems with the Insignia and Nexus pacemakers on September 22, 2005.
Problem

Guidant identified three potential problems with the Insignia and Nexus pacemakers:

  1. Intermittent or permanent loss of pacing output without warning.
  2. Intermittent or permanent loss of telemetry.
  3. Reversion to VVI mode or appearance of a reset warning message upon interrogation.
Reports of Injuries
As of September 6, 2005, Guidant was aware of 36 failures where the device would suffer an intermittent or permanent loss of pacing output. As of the same date, Guidant was aware of sixteen instances where the device suffered an intermittent or permanent loss of telemetry.
Models

The problems affect the following units:

Guidant Pacemakers
Guidant Intermedics Pacemakers
Device Family
Model Nos.
Device Family
Model Nos.
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
Recommendation
Patients should consult with their physicians to discuss their medical options.

Our Lawyers Can Help

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O'Steen & Harrison, PLC presently is handling legal claims on behalf of those injured by defective Guidant heart devices.

For free answers to your legal questions about the Guidant Insignia and Nexus Pacemakers, just call us toll-free at 1-800-883-8888 or submit this online contact form.

Guidant Insignia and Nexus Documents

Important Medical Device Safety Information & Corrective Action
Guidant Corp. | September 22, 2005

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