BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 1852041 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14776
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN ELECTED TO SURGICALLY CAP AND ABANDON THE RATE/SENSE PORTION OF THIS CHRONIC RV LEAD. A NEW RV RATE/SENSE LEAD WAS SUCCESSFULLY IMPLANTED, WITH NO ADVERSE PATIENT EFFECTS REPORTED. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION, THE TERMINAL PIN OF THIS CHRONIC TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD SEPARATED. SPECIFICALLY, THE METAL PORTION OF THE TERMINAL PIN SEPARATED FROM THE REST OF THE CONNECTOR WHEN THE RV TERMINAL PIN WAS PUSHED INTO THE HEADER OF THE NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 4137| 1782| T135| E102| 0125