BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY II

    MDR report key: 2172881 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10111
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    March 7, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HEADER WAS EXAMINED. VISUAL INSPECTION NOTED THAT THE VENTRICULAR RETAINER RING HAD A HOLE, AND THE SETSCREW SLOT HAD TIPS TO FLATS DAMAGE. ALL SETSCREWS MOVED FREELY AND OPERATED NORMALLY. AN IS-1 LEAD WAS INSERTED INTO BOTH PORTS, WITH NO ISSUES OBSERVED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. THE DEVICE WAS NOTED TO HAVE SYSTEM RESETS WHICH OCCURRED POST EXPLANT, HOWEVER BATTERY DEPLETION WAS DETERMINED TO BE NORMAL. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    TO DATE, THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS BEING ELECTIVELY CHANGED OUT. THIS DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI) BUT STILL HAD A MAGNET RATE OF 100. ON THE OPERATING TABLE, THE PHYSICIAN COULD NOT GET THE NON-BSC TRANSVENOUS RIGHT VENTRICULAR (RV) SET SCREW LOOSE. THE PHYSICIAN TRIED LUBRICATION AND THREE DIFFERENT TORQUE WRENCHES UNSUCCESSFULLY. THE PHYSICIAN DID NOT WANT TO ATTEMPT TO CUT THE DEVICE HEADER. THE PATIENT WAS NOTED AS DEPENDANT AND THERE HAD BEEN NO TEMPORARY WIRE PLACED. THE PHYSICIAN DETERMINED THAT THE ISSUE SHOULD BE BEST ADDRESSED BY A DIFFERENT PHYSICIAN IN A DIFFERENT FACILITY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT 6 MONTHS LATER THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THE SETSCREW OF THE DEVICE WAS ABLE TO BE UNSCREWED AND THE PREVIOUSLY STUCK NON BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD WAS ABLE TO BE REMOVED FROM THE HEADER AT THIS PROCEDURE AND IS BEING USED WITH THE CURRENT DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1286

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention 1286| MISMATCH