BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 448027 · Received March 12, 2003

    Report

    Report Number
    MW1027838
    Event Type
    Malfunction
    Date Received
    March 12, 2003
    Date of Event
    February 3, 2003
    Report Date
    March 5, 2003
    Manufacturer
    MEDTRONIC INC.
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEEP BRAIN STIMULATOR LEAD BECAME FRACTURED, DUE TO METAL FATIGUE.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 5/12/2003: AFTER SPEAKING WITH BIOMEDICAL ENGINEERING AT THE HOSPITAL, THEY FOUND OUT THE PRODUCT INVOLVED WAS THE EXTENSION NOT THE LEAD. THERE WAS NO PT INJURY INVOLVED WITH THE INCIDENT REPORTED, ONLY THE REPLACEMENT OF THE DEVICE. THE PRODUCT WAS NOT RETURNED SO THERE WAS NO ANALYSIS PERFORMED ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC DEEP BRAIN STIMULATOR LEAD MHY MEDTRONIC INC. 7495-51 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA