Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: SR (model 1392). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT 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. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. The INSIGNIA and NEXUS I Plus adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. 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.
This recall has been terminated (originally issued September 24, 2005).
- Company
- Guidant Corporation
- Recall Initiated
- September 22, 2005
- Posted
- September 24, 2005
- Terminated
- December 27, 2006
- Recall Number
- Z-0190-06
- Quantity
- 1784
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide and Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Polynesia, Portugal, Qatar, Reunion, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela
Lot / Code Info
INSIGNIA AVT SSI (model 482) serial no. 100005 - 100324; INSIGNIA AVT VDD (model 882) serial no. 100006 - 100410; INSIGNIA DDD (model 982) serial no. 100007 - 100473; INSIGNIA AVT SR (model 1192) serial no. 100008 - 100473; NEXUS AVT SR (model 1392) serial no. 100016 and 100020; INSIGNIA AVT DR (model 1292) serial no. 100007 - 100798.
Root Cause
Other
Action Taken
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.