BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II VR

    MDR report key: 3890510 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04504
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED DEVICE RESET WAS OBSERVED AFTER INAPPROPRIATE SHOCK FOR SUPRAVENTRICULAR TACHYCARDIA. AT TIME OF SHOCK, THE DEVICE WAS REPROGRAMMED TO ORIGINAL SETTINGS. TECHNICAL SERVICES ASSISTED IN RESOLVING THE RESET THROUGH THE ENGINEERING TEST PAGE. AFTER REPROGRAMMING IT WAS FOUND THE RIGHT VENTRICULAR LEAD IMPEDANCE HAD INCREASED BY OVER DOUBLE THE BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31238 EPIC II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D V-158

    Patients

    Seq Age Sex Outcome Treatment
    1