BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3854625 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11490
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INCREASED HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. THE DEVICE WAS SITTING AT A STRANGE ANGLE IN THE POCKET. THE PHYSICIAN REPOSITIONED AND BURIED THE DEVICE FURTHER INSIDE THE POCKET. ALL ELECTRICAL MEASUREMENTS WERE NORMAL. THE PATIENT CONDITION WAS WELL AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332120 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2359-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention