BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1162261 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05833
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Report Date
    August 19, 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
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S STIMULATION DEVICE WAS STUCK ON ABOUT THREE MONTHS AGO. IT TOOK FOUR HOURS TO GET THE STIMULATION TURNED OFF. THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION. THE PATIENT'S ARM WAS CRAMPED AND SHE COULDN'T FEEL HER FINGERS. THE PATIENT STILL HAS THE DEVICE IMPLANTED. IT REMAINS OFF. SEE MFR REPORT # 3004209178-2008-05842. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    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 Required Intervention EXPLANTED:| EXTENSION: MODEL 7489| EXPLANTED:| LEAD: MODEL 3987A| PROGRAMMER: MODEL 7434A