BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPATH

    MDR report key: 1951635 · Received January 6, 2011

    Report

    Report Number
    2124215-2011-00047
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    NHW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WILL BE EXPLANTED DUE TO AND INFECTION AND POCKET EROSION. IT WAS NOTED THAT THE HEADER OF THE DEVICE IS EXPOSED AND THE PATIENT IS PACEMAKER DEPENDENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPATH IMPLANTABLE LEAD NHW EXTERNAL MANUFACTURER 4046

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention N119| 0184| 4470| 4047| 4046| 4968| 0185