BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1213078 · Received October 23, 2008

    Report

    Report Number
    3004209178-2008-06815
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT BEGAN FEELING STIMULATION THAT WAS "RADIATING OUT" INSTEAD OF PULSING AS USUAL. THE STIMULATION CHANGED ABOUT TWO WEEKS PRIOR. THE PATIENT HAD DRIVEN A CAR THAT HAD MAGNETS IN THE CAR SEAT. THE PATIENT TURNS HIS STIMULATOR OFF WHEN DRIVING. WHEN HE SAT IN THE CAR, THE STIMULATION UNIT TURNED ON. THE PATIENT ATTEMPTED TO MAKE ADJUSTMENTS WITH THE PATIENT PROGRAMMER, BUT IT WAS NOT HELPING THE STIMULATION PATTERN. THE PATIENT IS SEEKING A NEW PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR IMPLANTED:| EXTENSION: MODEL 7495LZ| IMPLANTED:| LEAD: MODEL 3587A| PROGRAMMER: MODEL 7434| EXPLANTED:| EXPLANTED: