BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1771643 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-14745
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 9, 2003
    Report Date
    June 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR POST MARKET QUALITY ASSURANCE LABORATORY FOUND THAT THE DEVICE PACED AND SENSED NORMALLY, COMMUNICATED APPROPRIATELY WITH THE PROGRAMMER AND PASSED ALL MANUAL ELECTRICAL MEASUREMENTS. BASED IN THIS, OUR ANALYSIS CONCLUDED THAT THIS DEVICE EXHIBITED NORMAL FUNCTION DURING TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE PACEMAKER (IPM) WAS GIVING INCONSISTENT BATTERY MEASUREMENTS SHORTLY AFTER IMPLANT. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR 4271| 4285| 1230| 1298