BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS VR

    MDR report key: 2242941 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06632
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    June 10, 2011
    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. OTHER TEXT: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOSS OF COMMUNICATION WAS CONFIRMED AND WAS DUE TO LOW BATTERY VOLTAGE. A LONGEVITY CALCULATION FOUND THE DEVICE BELOW THE EXPECTED LIMITS. BENCH, ATE TESTS WERE PERFORMED AND NO SOURCES OF HIGH CURRENT WERE FOUND. THE BATTERY WAS SENT TO THE MANUFACTURER AND NO ANOMALIES WERE FOUND THAT WOULD CAUSE PREMATURE BATTERY DEPLETION. THE CAUSE OF THE LOW BATTERY VOLTAGE WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED.

    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 69 YR Required Intervention