BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 1944909 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19444
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    September 30, 2010
    Report Date
    October 2, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE PACE/SENSE PORTION OF THE RV LEAD WAS SURGICALLY ABANDONED DUE TO OVERSENSING AND PACING INHIBITION. A NEW PACE/SENSE LEAD WAS SUCCESSFULLY IMPLANTED. THE DEFIBRILLATION PORTION OF THIS LEAD REMAINS IN SERVICE. AS THE LEAD WILL NOT BE RETURNED, CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. 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 THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXHIBITING EARLY SIGNS OF A FRACTURE. OVERSENSING WAS NOTED AND THE PATIENT WAS SYMPTOMATIC. THE DEVICE WAS PROGRAMMED TO LEAST SENSITIVITY. THE CALLER WONDERED IF RATE SMOOTHING OR INCREASING THE LOWER RATE LIMIT COULD PROVIDE ADDITIONAL PACING. TECHNICAL SERVICES (TS) DISCUSSED THAT THERE IS NO PROGRAMMING/ALGORITHMIC SOLUTION FOR OVERSENSING OTHER THAN SENSITIVITY. THE CALLER WILL DISCUSS WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention T165| 1270| 0154| 1861| 4054| 4055| 4518| H219