BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONICS

    MDR report key: 374208 · Received January 10, 2002

    Report

    Report Number
    374208
    Event Type
    Other
    Date Received
    January 10, 2002
    Date of Event
    October 3, 2001
    Report Date
    December 12, 2001
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AICD LEAD WIRE WAS DISLODGED. SUTURE COLLAR FAILED TO STABILIZE DESPITE ROTORS TIGHTLY FASTENED. PT MADE FULL RECOVERY WITH LEAD REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONICS LV LEAD WIRE LWS MEDTRONIC INC. 2187-LV *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other