BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2171311 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11094
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    August 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED MECHANICAL AND ELECTRICAL TESTING WAS PERFORMED ON THE DEVICE. THE DEVICE BATTERY STATUS WAS [EOL]. THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. ANALYSIS CONCLUDED THAT THE DEVICE OPERATED WITHIN ELECTRICAL SPECIFICATIONS DURING PACING AND SENSITIVITY TESTING. IT WAS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DECLARED [EOL] EARLIER THAN PREVIOUSLY ESTIMATED. DETAILED MECHANICAL AND ELECTRICAL TESTING WAS PERFORMED. THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. ANALYSIS CONCLUDED THIS DEVICE DID NOT EXPERIENCE A COMPONENT MALFUNCTION OR PREMATURE BATTERY DEPLETION, AND REPLACEMENT INDICATORS WERE DISPLAYED APPROPRIATELY RELATIVE TO THE ACTUAL BATTERY CONDITION. HOWEVER, SERVICE LIFE FELL SLIGHTLY SHORT OF LONGEVITY EXPECTATIONS AS OUTLINED IN THE INSTRUCTIONS FOR USE ORIGINALLY APPROVED FOR AND DISTRIBUTED WITH THIS DEVICE. LONGEVITY ESTIMATION TOOLS HAVE SINCE BEEN REFINED TO BETTER REFLECT ACTUAL DEVICE PERFORMANCE AND CURRENT CLINICAL PRACTICES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DISPLAYED A BATTERY DEPLETION ANOMOLY. A FEW MONTHS AGO, THE DEVICE LONGEVITY WAS AT 1.5 YEARS. CURRENTLY THE DEVICE WAS AT ELECTIVE REPLACEMENT TIME (ERT). IT WAS NOTED THERE WERE NO PROGRAMMING CHANGES MADE OR CHANGES IN THE DEVICE FUNCTION OR DIAGNOSTICS. A CHANGE OUT PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR 1290| 4054| 4088| 1298