BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 1945549 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19870
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    August 13, 2010
    Report Date
    October 11, 2010
    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

    IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A RIGHT ATRIAL (RA) LEAD REVISION PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD WAS RECONNECTED. WHEN RE-CONNECTING THE RV LEAD, THE INSULATION WAS FOUND TO BE SEPARATED RESULTING IN NOISE. THE LEAD WAS, AGAIN SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 74 YR H210| 0155| 4543| 4087| 1861