BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2163064 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07359
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE ON THE PACE/SENSE CHANNEL RESULTING IN FOUR SECONDS OF PACING INHIBITION AND CAUSED DETECTION. THERE WAS NO INAPPROPRIATE SHOCKS. A REVISION PROCEDURE WAS PERFORMED AND THE RV AND THE COMPETITOR'S LEFT VENTRICULAR (LV) LEADS WERE SWITCHED IN THE HEADER. IT WAS NOTED THAT THE PATIENT IS DEPENDENT BUT HAD NO SYNCOPE AS A RESULT OF THE PACING INHIBITION. TECHNICAL SERVICES (TS) DISCUSSED IMPLICATIONS OF THE PACE/SENSE LEADS BEING SWITCHED IN THE HEADER. THE FIELD REPRESENTATIVE INDICATED THAT THEY INDUCED THE PATIENT AND HAD APPROPRIATE DETECTION AND THERAPY. THERE WERE CONCERNS OF RV OVERSENSING IN THE LV PORT AND STILL HAVING PACING INHIBITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0155

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention T125| 1831| 4054| 0155| (B)(4)| V-337| H227