BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1140623 · Received August 28, 2008

    Report

    Report Number
    9614453-2008-05300
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 30, 2008
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS "NOT GETTING STIMULATION ALL THE TIME, OR WAS NOT GETTING STIMULATION ON ALL SETTINGS". IMPEDANCES WERE CHECKED AND FOUND TO BE >4000 OHMS ON ALL OR SOME OF THE BIPOLAR PAIRS. THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO INVESTIGATE FURTHER BEFORE SHE DECIDED TO REPLACE THE LEAD AND/OR EXTENSION. THEY PLANNED TO ATTEND THE PATIENT'S PLACE OF WORK TO DO AN ASSESSMENT; THE HCP FELT THE PROBLEM MAY BE WORK RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC EUROPE SARL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL 7489 LOT# NHU080627V| IMPLANTED:| LEAD MODEL 3487A LOT# B0720215K| IMPLANTED:| EXPLANTED:| EXPLANTED: