BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052887 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-06430
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED FOR LABORATORY ANALYSIS. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED ABNORMAL PACING IMPEDANCE MEASUREMENTS, AND THE ASSOCIATED DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). A REVISION PROCEDURE WILL TAKE PLACE IN THE NEAR FUTURE. PRINTOUTS WERE SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) FOR REVIEW. BSC TS DISCUSSED THAT THE GRADUAL INCREASE IN RV PACE IMPEDANCE WITH NO CHANGE IN THE OTHER MEASUREMENT COULD MOST LIKELY BE LINKED TO A CALCIFICATION OF THE LEAD TIP. A SPECIFIC BEHAVIOR OF THIS CALCIUM DEPOSIT IS THE INCREASE IN PACING IMPEDANCE WITHOUT CHANGE IN STIMULATION THRESHOLD. IT WAS ALSO DISCUSSED THAT THE PACING THERAPY CAN'T BE MONITORED ANY LONGER BECAUSE THE PACING IMPEDANCE IS OUT OF RANGE. IT WAS SUGGESTED THAT IF THE DEVICE IS GOING TO BE REPLACED, THEN THE PHYSICIAN MIGHT CONSIDER REPLACING THE LEAD. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THE ASSOCIATED CRT-D WAS REPLACED, AND A NEW EXTRA RV LEAD WAS ADDED. THE PATIENT NOW HAS FOUR LEADS IMPLANTED. THE REPLACEMENT PROCEDURE WAS PERFORMED WITHOUT COMPLICATIONS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1