BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC II PLUS DR

    MDR report key: 3210456 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03542
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 4, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF NO COMMUNICATION COULD NOT BE CONFIRMED. THE DEVICE SUCCESSFULLY ESTABLISHED COMMUNICATION LABORATORY. THE CAUSE OF THE FIELD EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED ATTEMPTED DIFFERENT WAND POSITIONS BUT WAS UNSUCCESSFUL THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309736 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 55 YR Required Intervention (B)(4)