BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II PLUS DR

    MDR report key: 3090210 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01284
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 20, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC AND UPON INTERROGATION, A SOFTWARE RESET WAS DETECTED. THE PATIENT RECENTLY UNDERWENT A COMBINATION OF RADIATION TREATMENT AND KNEE SURGERY. THE DEVICE WAS RESTORED IN NORMAL SETTING BY DOWNLOADING DEVICE CODE AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192226 EPIC II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-258 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR