BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC II PLUS DR

    MDR report key: 4170098 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02909
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    April 17, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THE REPORTED FIELD EVENT OF OUTPUT CIRCUIT DAMAGE WAS CONFIRMED IN THE LABORATORY. ANALYSIS FOUND TWO OF THE HV TRANSISTORS SHORTED. THE DEVICE WAS TESTED USING THE AUTOMATED TEST SYSTEM AND MET ALL TEST SPECIFICATIONS. THE CAUSE OF THE OUTPUT CIRCUIT DAMAGE IS BELIEVED TO BE A DAMAGED LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO HV CIRCUIT DAMAGE CAUSED BY MALFUNCTIONING DEFIB. LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23718 EPIC II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD V-258

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention