BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC PLUS DR

    MDR report key: 1073519 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02413
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    April 1, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD MOVED TOWARDS THE BELLY BUTTON, AND WILL BE REPOSITIONED TO THE APPROPRIATED AREA. THE DEVICE REMIANS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-239 NA

    Patients

    Seq Age Sex Outcome Treatment
    1