BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT ACCEL DR, DF-4 CONNECTOR

    MDR report key: 3872900 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11791
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY AND WAS CAUSED BY A POWER-ON RESET. REVIEW OF THE DEVICE IMAGE INDICATED THE CAUSE OF THE POWER-ON RESET WAS HV THERAPY DELIVERY INTO A LOW IMPEDANCE OUTPUT. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY AS FOUND. THE CAUSE OF THE LOW IMPEDANCE OUTPUT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED. THE PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350276 CURRENT ACCEL DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2215-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention