BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 1853532 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14781
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LEAD WAS ABANDONED AND WILL NOT BE RETURNED; THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE ROUTINE CHANGEOUT PROCEDURE, THE PROXIMAL COIL OF THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS DAMAGED. THE LEAD WAS SURGICALLY ABANDONED. THERE WAS NOT AN ALLEGATION OF MALFUNCTION AGAINST THE LEAD. THE REPLACEMENT PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other