BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3211021 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08558
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS ANALYZED. A LONGEVITY CALCULATION WAS PERFORMED, WHICH CONFIRMED THE DEVICE HAD FAILED TO MEET LONGEVITY EXPECTATIONS. THE DEVICE CASE WAS OPENED AND THE BATTERY WAS REPLACED WITH AN EXTERNAL POWER SUPPLY. ELECTRICAL MEASUREMENTS NOTED A HIGH CURRENT CONDITION. FURTHER DETAILED ANALYSIS ISOLATED THE HIGH CURRENT CONDITION TO A DEGRADED LOW-VOLTAGE CAPACITOR, CAUSING THE REPORTED FIELD OBSERVATION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. THERE WAS CONCERN THAT THE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309976 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R