BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 2172956 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10246
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    May 24, 2011
    Report Date
    July 21, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS DEVICE HAS NOT BEEN RETURNED IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS PRODUCT WAS INSPECTED AND A HOLE ALL OF THE SEAL PLUGS WAS OBSERVED. TESTING VERIFIED NORMAL ELECTRICAL FUNCTION. SETSCREW SEAL PLUGS ARE DESIGNED TO PERMIT SETSCREW WRENCH INSERTION WHILE PREVENTING BODY FLUIDS FROM ENTERING THE HEADER CAVITIES. ON OCCASION, WRENCH PENETRATION CAN DAMAGE A SEAL PLUG WHICH CAN LEAD TO ACCESSORY SENSING PATHWAYS AND POTENTIALLY RESULT IN OVERSENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. THEY ATTEMPTED TO RECREATE THE NOISE WHICH WAS SUCCESSFUL WITH ARM MOVEMENT. THERE WERE NO IMPEDANCE MEASUREMENTS TAKEN DURING THE ISOMETRICS. THE PACING IMPEDANCE MEASUREMENTS WERE STABLE AND WITHIN NORMAL LIMITS. IT WAS NOTED A DEVICE CHANGE OUT PROCEDURE WOULD BE PERFORMED IN THE NEAR FUTURE. SUBSEQUENTLY, THE DEVICE DISPLAYED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS DURING THE DEVICE CHANGE OUT PROCEDURE. THE SHOCK IMPEDANCE AND THRESHOLD MEASUREMENTS WERE WITHIN NORMAL LIMITS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT DURING THE DEVICE CHANGE OUT PROCEDURE NO NOISE WAS OBSERVED AND NO NEW RATE/SENSE LEAD WAS IMPLANTED. AT THIS TIME, THE PHYSICIAN WILL DISCUSS OPTIONS WITH THE PATIENT REGARDING OPTIONS TO MITIGATE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CLONMEL IRELAND 1860

    Patients

    Seq Age Sex Outcome Treatment
    1 10168 DA 0145| 1790| 1860