BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2060153 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05688
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC ENGINEER INFORMED THE CALLER HOW TO CLEAR THE FAULT AND RESET THE SYSTEM. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD EXHIBITED A LOW SHOCK IMPEDANCE OF 18 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 1790| 4554| H210| T135| 4136| 0145