BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2151474 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06025
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THE PHYSICIAN IS AWARE AND PLANS TO MONITOR THE LEAD. THERE ARE NO PLANS FOR ADDITIONAL INTERVENTION AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA LATITUDE REMOTE MONITORING THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THERE WAS NO NOISE PRESENT ON THE PRESENTING ELECTROGRAM. A REVIEW OF THE PACING IMPEDANCE MEASUREMENTS DID NOT SHOW AN UPWARD TREND, BUT INSTEAD INDICATED THE MEASUREMENTS MOVED UP AND DOWN. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0144

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR E110| 1831| 1861| 4469| 0144| 4244