BEUDAMED
    FDA Adverse Event Summary report: N

    EPIC II PLUS DR

    MDR report key: 1010778 · Received March 10, 2008

    Report

    Report Number
    2017865-2008-01029
    Date Received
    March 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED RESET WAS CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE DEVICE WAS FOUND TO BE IN HARDWARE VVI (HWVVI) BACKUP. AFTER REMOVING THE HWVVI, IT FUNCTIONED NORMALLY ON THE BENCH. THE DEVICE WAS TESTED ON THE AUTOMATED TESTING SYSTEM AND MET ALL SPECIFICATIONS. THE CAUSE OF THE PARITY ERROR COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING THE JETSTREAM G3 DEVICE AND THE TIP OF THE WIRE BECAME SHEARED OFF. THE PHYSICIAN NOTICED THERE WAS A PROBLEM AND LOCATED THE TIP OF THE WIRE. PHYSICIAN USED A SNARE TO CAPTURE THE WIRE FRAGMENT AND SUCCESSFULLY REMOVED IT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1