BEUDAMED
    FDA Recall Terminated

    Guidant INSIGNIA I Ultra --family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The Intermedics NEXUS I Ultra (models 1390, 1490, 1491) are not available in the US. The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant.--The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. 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. Quantities Distributed by model are as follows: INSIGNIA ULTRA SR model 1190 = 4,590; DR model 1290 = 9,654, model 1291 = 4,038. NEXUS ULTRA SR model 1390 = 15; DR model 1490 = 52, model 1491 = 57.

    Recall: Z-1294-06 · Initiated June 24, 2006

    Recall

    Recall Number
    Z-1294-06
    Event Number
    35754
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    LWP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 24, 2006
    Posted
    September 28, 2006
    Terminated
    March 2, 2008
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Guidant INSIGNIA I Ultra --family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The Intermedics NEXUS I Ultra (models 1390, 1490, 1491) are not available in the US. The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant.--The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. 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. Quantities Distributed by model are as follows: INSIGNIA ULTRA SR model 1190 = 4,590; DR model 1290 = 9,654, model 1291 = 4,038. NEXUS ULTRA SR model 1390 = 15; DR model 1490 = 52, model 1491 = 57.

    Reason

    Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion or loss of pacing output without warning in the affected devices.

    Action

    A Press Release was issued on 06/26/06. An Urgent Medical Device Safety Information & Corrective Action letter, dated 06/23/06 was delivered to physicians describing preliminary information before Guidant has completed its own investigation and finalized patient care recommendations. Non-implanted inventory is being retrieved from hospital shelves and Guidant Represenatatives. Physicians are to perform an in-clinic follow-up exam as soon as possible with patients implanted with affected devices.

    Distribution

    Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Micronesia, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela

    Quantity

    18,406