BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS VR

    MDR report key: 2243086 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06630
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    July 20, 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 Location
    TN
    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 OUTPUT ANOMALY WAS CONFIRMED IN THE LABORATORY. ANALYSIS FOUND TWO OF THE DEVICE'S HV OUTPUT TRANSISTORS WERE SHORTED, WHICH IS CONSISTENT WITH THAT CAUSED BY A DAMAGED LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A DEVICE CHECK AND UPON INTERROGATION; AN ALERT WAS PRESENT FOR POSSIBLE OUTPUT CIRCUIT DAMAGE. SYSTEM 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 69 YR Required Intervention (B)(4)