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Terminated

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.

FDA Recall Z-0193-06 · Posted 2005-11-23

Recalling FirmGuidant Corporation
Recall StatusTerminated
Product CodeDXY
Date Initiated2005-09-22
Date Terminated2007-01-05
Product Quantity174,848

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide and Arab Emerites, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan ROC, Thailand, Turkey, United Kingdom, Urguay and Venezuela

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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