BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2052721 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03984
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 26, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD PORTION HAS NOT BEEN RETURNED TO BOSTON SCIENITFIC. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) PACE/SENSE LEAD PORTION WAS PARTIALLY SURGICALLY ABANDONED AS A RESULT OF NOISE, SIGNIFICANT DROP IN RV PACE IMPEDANCE BUT NOT BELOW 250 OHMS, AND DROP IN SENSING AS WELL. THERE WAS A SUSPECTED INSULATION BREACH THAT LEAD TO AN INAPPROPRIATE SHOCK. THE NOISE COULD NOT BE REPRODUCED WITH ISOMETRICS. AT THE REVISION PROCEDURE, THERE WAS NO ISSUE WITH THE NEW RV LEAD AT THE SURGERY. HOWEVER, IT WAS NOTED THAT THE ATRIAL LEAD HAD NOISE, AND WAS VISUALLY CRUSHED/BENT BACK ON ITSELF WHEN THEY CONNECTED IT TO THE NEW DEVICE. THERE HAD BEEN NO INDICATION OF AN ATRIAL LEAD ISSUE PRIOR TO OPENING THE POCKET. THE IMPLANTING PHYSICIAN DECIDED NOT TO REPLACE THE ATRIAL LEAD, AND THE DEVICE WAS REPROGRAMMED TO VVI. THE LOCAL AREA SALES REPRESENTATIVE CONFIRMED THAT THERE HAD BEEN NO ASYSTOLE OR SYNCOPE AS A RESULT OF THE PRODUCT PERFORMANCE ISSUES.

    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 50 YR Required Intervention 0144| 4461| T127| 1851