BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS DR

    MDR report key: 1955227 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00567
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 17, 2010
    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
    SC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS NOT CONFIRMED IN THE LABORATORY. A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE WITHIN LONGEVITY ESTIMATIONS. TESTING ON THE AUTOMATED TEST EQUIPMENT FOUND NO ANOMALIES. DEVICE FUNCTION WAS DETERMINED TO BE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION.

    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 75 YR Required Intervention