BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT VR RF

    MDR report key: 4153489 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16302
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 21, 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 Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.THE REPORTED FIELD EVENT OF THE INABILITY TO ENGAGE THE SET SCREW WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION IDENTIFIED SILICONE, SEPTUM MATERIAL INSIDE THE VTIP SET SCREW HEX CAVITY. THIS MATERIAL PREVENTED FULL INSERTION OF THE TORQUE DRIVER IN THE HEX CAVITY AND RESULTED IN DIFFICULTY ENGAGING THE SET SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE OPERATING ROOM FOR LEAD REVISION. UPON RECONNECTING THE DEVICE TO THE NEW LEAD, PACE/SENSE SETSCREW WOULD NOT RE-ENGAGE. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631160 CURRENT VR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR