BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE ACCEL CRT-D

    MDR report key: 1895817 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04715
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 15, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT WAS CONFIRMED IN THE LABORATORY. A LONGEVITY CALCULATION WAS PERFORMED AND THE DEVICE LONGEVITY WAS FOUND TO BE OUTSIDE OF NORMAL LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED SYSTEM. NO HIGH CURRENT MEASUREMENTS WERE FOUND. THE BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. ANALYSIS FOUND AN INTERNAL BATTERY ANOMALY WHICH RESULTED IN THE PREMATURE BATTERY DEPLETION. .

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT, THE DEVICE SHOWED AN SIGNIFICANT DECREASE IN BATTERY VOLTAGE. NO THERAPY HAD BEEN DELIVERED SINCE IMPLANT. A LONGEVITY ESTIMATION OF THE BATTERY SHOWED THE DEVICE WAS AT ERI. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE ACCEL CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention