BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC II PLUS DR

    MDR report key: 1895864 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04772
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 13, 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 Location
    FL
    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 RESET ANOMALY WAS CONFIRMED IN THE LABORATORY. UPON INTERROGATION, THE DEVICE WAS FOUND IN HARDWARE RESET DUE TO MULTIPLE SOFTWARE AND MICRO-RESET PARITY ERRORS. VISUAL INSPECTION FOUND A SMALL POLISH MARK ON THE BACK OF THE ICD CAN. IT IS BELIEVED THAT EXTERNAL NOISE FROM THE REPORTED SURGICAL PROCEDURE AND A DAMAGED LEAD CONTRIBUTED TO THE PARITY ERRORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERROGATION, THE DEVICE DISPLAYED A HARDWARE RESET MESSAGE AFTER THE PATIENT HAD AN ENDOCSOPY PROCEDURE. INTERROGATION ATTEMPTED AGAIN WITH SAME ERROR MESSAGE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-258 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention