BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE ACCEL CRT-D

    MDR report key: 3210621 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03420
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 5, 2013
    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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY TO BE CAUSED BY A POWER ON RESET DURING HV THERAPY DELIVERY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TESTING EQUIPMENT AND NO ANOMALY WAS FOUND. THE CAUSE OF THE POWER ON RESET WAS NOT DETERMINED BECAUSE IT COULD NOT BE REPRODUCED DURING TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING A SHOCK. INTERROGATION REVEALED THE DEVICE WAS IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309395 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