BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS VR, DF-4 CONNECTOR

    MDR report key: 3903621 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12869
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BEING UNABLE TO LOOSEN THE SET SCREW WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION NOTED THE SET SCREW WAS STRIPPED. IT IS BELIEVED SILICONE DEBRIS FILLED THE SET SCREW HEX CAVITY, PREVENTED FULL INSERTION OF THE TORQUE DRIVER, AND RESULTED IN DIFFICULTY LOOSENING THE SET SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE UPGRADE, THE SCREW IN THE HEADER AND THE LEAD COULD NOT BE REMOVED. THE DEVICE AND LEAD WERE REPLACED. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381105 CURRENT PLUS VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1