BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1852713 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14583
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE DEVICE REPLACEMENT PROCEDURE, NOISE WAS OBSERVED ON THIS CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WHEN THEY CONNECTED THE LEAD TO THE NEW DEVICE. WHEN THE LEAD WAS TUGGED ON, IT EASILY CAME OUT OF DEVICE HEADER. THE LEAD WAS REINSERTED AND THE SETSCREWS WERE FULLY TIGHTENED. APPROXIMATELY TEN TO FIFTEEN SECONDS FOLLOWING DEFIBRILLATION THRESHOLD TESTING, OVERSENSING WAS NOTED ON THE RV CHANNEL AND PACING WAS INHIBITED FOR A FEW SECONDS. THE PATIENT IS PACEMAKER DEPENDENT. THE NOISE RESEMBLED THAT WHICH OCCURS WHEN AIR BUBBLES EQUALIZE THROUGH THE SEAL PLUGS AT IMPLANT. THE LEAD WAS CHECKED USING THE PACING SYSTEM ANALYZER AND ALL DIAGNOSTICS WERE WITHIN RANGE. THE LEAD WAS RECONNECTED TO THE DEVICE AND ARTIFACT WAS BRIEFLY NOTED AGAIN BUT AFTER THIS EVERYTHING APPEARED TO BE FINE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR T135| 0184