BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS VR

    MDR report key: 1895846 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04760
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 10, 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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF DEVICE RESET WAS CONFIRMED IN THE LABORATORY. ANALYSIS OF THE MEMORY MAP SHOWED THE DEVICE ENTERED HARDWARE VVI MODE ON (B)(6) 2010 DUE TO A POR (POWER-ON RESET). EXAMINATION OF DIAGNOSTIC DATA SHOWED THAT THE DEVICE DELIVERED 106 HIGH VOLTAGE SHOCKS BETWEEN (B)(6) 2010 AND THE RESET TIME. THE DEVICE'S FUNCTIONALITY WAS TESTED AND THE DEVICE PASSED ALL TESTS. ALL POWER CONSUMPTION MEASUREMENTS WERE NORMAL. IT IS BELIEVED THAT THE CAUSE OF THE POR WAS DUE TO NORMAL BATTERY DEPLETION THAT RESULTED AFTER A LARGE VOLUME OF HIGH VOLTAGE THERAPY SHOCKS WERE DELIVERED.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING MULTIPLE SHOCKS. THE PATIENT RECEIVED ANOTHER AFTER BEING ADMITTING. DEVICE INTERROGATION LATER SHOWED THAT THE DEVICE WAS IN VVI MODE. IT WAS NOTED THAT THE PATIENT HAS RECURRENT VT.

    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 68 YR Required Intervention