BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1180197 · Received September 29, 2008

    Report

    Report Number
    2182207-2008-06192
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    January 1, 2002
    Report Date
    September 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    THE PT UNDERWENT MAGNETIC RESONANCE IMAGING AND THE IMPLANTABLE NEUROSTIMULATOR HYBRID CIRCUIT LOCKED UP. THE DEVICE WAS REPLACED. NO OTHER PT SYMPTOMS OR DEVICE TROUBLESHOOTING WAS REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention