BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3211621 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09023
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SIGNIFICANT INCREASE PACING IMPEDANCES AND THRESHOLD MEASUREMENTS OVER THE PAST FEW MONTHS. A REVIEW OF THE STORED ELECTROCARDIOGRAMS DID NOT REVEAL ANY NOISE. ALTHOUGH THE LEAD MEASUREMENTS ARE STILL WITHIN NORMAL LIMITS, TECHNICAL SERVICES RECOMMENDED THAT INTERVENTION AND NOT WAIT FOR THE ASSOCIATED DEVICE TO REACH REPLACEMENT TIME APPROXIMATELY 1.5 YEARS FROM NOW. THE PATIENT WAS EVALUATED BY THE PHYSICIAN AND THE DECISION WAS MADE TO CONTINUE TO MONITOR FOR NOW. NO SURGICAL INTERVENTION IS PLANNED AT THIS TIME. THE LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310356 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR MISMATCH| 4518| H175| 0145| 1793| 4087