BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2040772 · Received March 22, 2011

    Report

    Report Number
    3007566237-2011-02199
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN A PERSON ON A CELL PHONE WALKS BY THE PT, THE DEVICE THEN NEEDS TO BE REPROGRAMMED.

    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