Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Plus models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Recall
- Recall Number
- Z-0193-06
- Event Number
- 33871
- Firm
- Guidant Corporation
- FEI Number
- 2124215
- Product Code
- DXY
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 22, 2005
- Posted
- November 23, 2005
- Terminated
- January 5, 2007
- Address
- 4100 Hamline Ave N, Saint Paul, MN, 55112-5798
Description
Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Plus models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Another failure mode, which occurs at a low rate, has been identified with 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.
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. UPDATE: Guidant is issuing an Advisory Update to physicians in December 2005. This update provides information relative to the failure mode including the identified cause; FDA's classification; Guidant representatives will retrieve and replace any hospital inventory with product free from "Mode 2" peri-implant failure; and recommended actions.
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