BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE

    MDR report key: 1944598 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20007
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ADVERSE EVENTS REPORTED FOLLOWING THIS INVASIVE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR A SCHEDULED DEVICE REPLACEMENT DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). WHEN THE POCKET SITE WAS OPENED, THE PHYSICIAN FOUND THAT THE POCKET WAS INFECTED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WILL BE SCHEDULED A SYSTEM EXTRACTION IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 432-04

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L 432-04| 101-09| 1861| 497-23| H177| 4549