BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1951575 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23501
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    January 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A COMPREHENSIVE SERIES OF DIAGNOSTIC AND ELECTRICAL TESTS WERE CONDUCTED, VERIFYING THE PERFORMANCE OF PACING, SENSING, AND MEMORY RECORDING FUNCTIONS. THE OBSERVATION OF THE UNEXPECTED INDICATOR WAS DUE TO THE PROGRAMMING CHANGES AND VARYING VENTRICULAR LEAD IMPEDANCES WHICH DIRECTLY AFFECT THE LONGEVITY OF THE DEVICE. THE LOWER VENTRICULAR LEAD VALUES WOULD HAVE RESULTED IN A HIGHER BATTERY CONSUMPTION. THE DEVICE EXCEEDED THE NOMINALLY PREDICTED LONGEVITY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW-UP VISIT, THIS PACEMAKER DISPLAYED A BATTERY GAUGE OF 1/4 AND ONE YEAR LONGEVITY REMAINING. EIGHT MONTHS LATER, THE DEVICE WAS FOUND TO HAVE UNEXPECTEDLY REACHED END OF LIFE (EOL). IT WAS NOTED THAT THE RIGHT VENTRICULAR OUTPUT HAD BEEN INCREASED TO 4.5V BETWEEN THE FOLLOW-UP APPOINTMENTS. TECHNICAL SERVICES WAS CONTACTED AND STATED THAT PACING CANNOT BE GUARANTEED AT EOL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    OUR COMPANY RECEIVED ADDITIONAL INFORMATION ONE MONTH LATER THAT THE PACEMAKER WAS EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS.

    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 70 YR Hospitalization| R 4473| 1298| 4472