BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPATH

    MDR report key: 1852648 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14538
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 CRM REVIEWED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO POCKET EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPATH IMPLANTABLE LEAD LWS EXTERNAL MANUFACTURER 4047

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 1888TC| 7121| 4554| N119| T165| 4047| 1488T| 0158| 4470| 1861