BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1961595 · Received December 27, 2010

    Report

    Report Number
    9614453-2010-10767
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 13, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO REPORTING THE PT HAD NOTICED THE STIMULATOR SEEMS TO EITHER REDUCE THE AMPLITUDE AND NEEDS TO BE TURNED UP SIGNIFICANTLY OR BE TURNED OFF COMPLETELY. THE CHANGE DOES NOT CORRELATE TO THE CHANGE IN STIMULATION FROM A POSITION CHANGE. WHEN IT IS TURNED OFF THE PT PROGRAMMER IS NEEDED TO TURN THE DEVICE BACK ON OR IT SOMETIMES WILL TURN BACK ON UNEXPECTEDLY. THERE IS NO PATTERN TO THESE CHANGES. IMPEDANCES ARE NORMAL AND THE AREA OF STIMULATION IS UNCHANGED. THE PT ESPECIALLY FINDS THIS FRUSTRATING WHEN LYING DOWN AT NIGHT AS HE LIKES TO HAVE THE STIMULATION ON TO HELP HIM SLEEP. THE PT WAS SEEN FOR REPROGRAMMING AT THE CLINIC, IMPEDANCES WERE CHECKED AND THE CONTROL MAGNET SETTING WAS TURNED OFF. THIS WAS DONE TO HELP PREVENT ANY POSSIBLE EMI THAT COULD BE CAUSING THE CHANGES. THE ISSUES COULD NOT BE REPRODUCED IN THE CLINIC SETTING AS IT ONLY OCCURS SPORADICALLY DURING THE DAY.

    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