BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1946229 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-21681
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    January 24, 2011
    Manufacturer
    GUIDANT CRM 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

    --

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT A REVISION PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE TO IMPLANT A NEW DEVICE AND RV LEAD. IT WAS NOTED THAT THRESHOLD MEASUREMENTS HAVE INCREASED TO 1.4 VOLTS AND 0.6 MILLISECONDS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. IT WAS NOTED THAT THRESHOLD MEASUREMENTS AND SHOCK IMPEDANCE MEASUREMENTS ARE NORMAL AND STABLE. TECHNICAL SERVICES (TS) RECOMMENDED, SINCE THE THRESHOLD MEASUREMENTS AND SHOCK IMPEDANCE MEASUREMENTS WERE NORMAL, TO CONTINUE MONITORING THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 0064| 0157| (B)(4)| 1860| 1746