BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 1894486 · Received November 9, 2010

    Report

    Report Number
    2124215-2010-21570
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE PATIENT EFFECTS HAVE BEEN OBSERVED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS EXPLANTED DUE TO A PATIENT INFECTION.

    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 64 YR Required Intervention N118| 6945| 4513| H179| MISMATCH| 1823| 0155| 4469