BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 1951456 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22851
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT HAS BEEN SCHEDULED FOR DEVICE AND LEAD SYSTEM EXTRACTION DUE TO INFECTION.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS DEVICE AND TWO LEADS WERE EXPLANTED DUE TO INFECTION. TWO LEADS COULD NOT BE EXTRACTED. THE LEADS WERE SURGICALLY CAPPED AND ABANDONED.

    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 84 YR Hospitalization| L| R 4087| 1831| 0155| 4054| 4549| H227| 4592| T125| 4555