BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950481 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23201
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 12, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION WAS PERFORMED AND IT WAS DETERMINED THAT THE TERMINAL PIN FOR THE PROXIMAL DEFIBRILLATION COIL WAS LOOSE IN THE HEADER. THE PIN WAS RE-CONNECTED TO THE HEADER AND ALL MEASUREMENTS WERE WITHIN NORMAL RANGE. THE LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD PRESENTED WITH SHOCK IMPEDANCE MEASUREMENTS ABOVE 125 OHMS. IN ADDITION, NOISE COULD BE OBSERVED DURING POCKET MANIPULATION AND WITH PATIENT MOVEMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR FURTHER ASSISTANCE. A TS REPRESENTATIVE DISCUSSED SEVERAL TROUBLESHOOTING TECHNIQUES TO DETERMINE IF IT WAS A CONNECTION ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SERIAL NUMBER FOR THIS LEAD IS CURRENTLY UNKNOWN AND ATTEMPTS TO OBTAIN THIS INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention