BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1771612 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13602
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    April 21, 2009
    Report Date
    June 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE DISPLAYED TWO DIFFERENT BATTERY LONGEVITY INDICATORS. THE MAGNET RATE REMAINED THE SAME, HOWEVER THE REMAINING LONGEVITY INDICATOR INCREASED WITHOUT PROGRAMMING CHANGES. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED PERFORMING A MEMORY DOWNLOAD. NO ADVERSE PATIENT EFFECTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 0882

    Patients

    Seq Age Sex Outcome Treatment
    1