BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC PLUS VR

    MDR report key: 3920906 · Received July 8, 2014

    Report

    Report Number
    2938836-2014-13327
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 22, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. THE REPORTED SETSCREW ANOMALY WAS CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE RV SEPTUM WAS NOTED TO BE REMOVED AND THE SETSCREW STRIPPED. A SECTION OF LEAD WAS STUCK IN THE RV PORT. THE CAUSE OF THE SETSCREW ANOMALY WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE DUE TO NORMAL ERI, A STRIPPED SETSCREW ANOMALY WAS OBSERVED. THE LEAD COULD NOT BE REMOVED FROM THE DEVICE THEREFORE THE LEAD WAS CUT AND CAPPED AND THE DEVICE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398350 EPIC PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-196 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 1591/60,RY11278