BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3040689 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01708
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE PRODUCT IS NOT EXPECTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE REPLACEMENT, THE INNER CONDUCTOR OF THIS CHRONIC IMPLANTABLE DEFIBRILLATION LEAD, SEPARATED FROM THE OUTER INSULATION AT THE PROXIMAL ANODE RING AFTER A LIGHT TUG ON THE LEAD TO VERIFY CONNECTION TO THE DEVICE HEADER. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. IT IS UNKNOWN IF THIS LEAD WAS EXPLANTED OR IF IT WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142865 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0144

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 1790| MISMATCH| 0144