BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC II VR

    MDR report key: 1831086 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03627
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 21, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    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 RESET OCCURRED DUE TO A POWER ON RESET DURING AN AUTOMATED CAPACITOR MAINTENANCE OPERATION PERFORMED PRIOR TO IMPLANT. ANALYSIS FOUND AN ANOMALY IN A HV CAPACITOR CONNECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO A RESET ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention