BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS VR

    MDR report key: 1896076 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04759
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 3, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE DEVICE WAS RECEIVED IN RESET MODE DUE TO A POWER ON RESET. THE POWER ON RESET OCCURRED WITHIN 20 SECONDS OF A HIGH VOLTAGE CHARGE. THE INITIAL CHARGING OCCURRED DUE TO OVERSENSING OF NOISE. AFTER REMOVAL OF THE RESET, BENCH AND AUTOMATED TESTS OF THE DEVICE FOUND NORMAL CHARACTERISTICS. IT IS BELIEVED THAT THE ANOMALY WAS A RESULT OF A LEAD DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP THE DEVICE WAS FOUND IN A BACKUP VVI MODE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-196 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention GUIDANT 0148 (B)(4)