BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIFIX

    MDR report key: 1945751 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20404
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE OUT PROCEDURE THIS CHRONIC LEAD WAS PLUGGED INTO A NON-BOSTON SCIENTIFIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. AFTER THE SETSCREW ON THE DEVICE HEADER WAS TIGHTENED DOWN, A LEAD TUG TEST WAS PERFORMED AND THE TERMINAL PIN STAYED IN THE HEADER OF THE DEVICE; HOWEVER, THE RING ALONG WITH SOME OF THE LEAD'S INSULATION CAME OUT OF THE HEADER. THE SETSCREW WAS LOOSENED AND THE TERMINAL PIN WAS REMOVED, THE LEAD WAS PUT BACK TOGETHER AND TESTED WITH THE PACING SYSTEM ANALYZER. THE LEAD WAS SUBSEQUENTLY PLUGGED BACK INTO THE DEVICE, AND NOTED TO BE WORKING APPROPRIATELY. THE PHYSICIAN CONSULTED TECHNICAL SERVICES TO SEE IF THE LEAD WAS OKAY TO USE. BOSTON SCIENTIFIC TECHNICAL SERVICES ADVISED THE PHYSICIAN THAT THE LEAD'S INTEGRITY WAS COMPROMISED AND SUGGESTED IMPLANTING A NEW LEAD. IT IS UNKNOWN AT THIS TIME IF THIS LEAD REMAINS IMPLANTED AND IN USE OR IF THE PHYSICIAN OPTED TO IMPLANT A NEW LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIFIX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 438-05

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR MISMATCH| (B)(4)