BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1231038 · Received October 30, 2008

    Report

    Report Number
    3004209178-2008-07040
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    OTHER: FOR TURNING ITSELF ON.

    Description of Event or Problem · 1

    THE IMPLANTABLE NEUROSTIMULATOR TURNED ITSELF ON AND OFF APPROX 8 TIMES IN ONE MONTH. THE PT WASN'T EXPOSED TO ANY ELECTRO-MAGNETIC INTERFERENCE. THE REMAINING BATTERY LIFE EXPECTANCY WAS APPROX 8 MONTHS. THE READ SWITCH (FEATURE THAT ALLOWS PTS TO TURN THEIR NEUROSTIMULATORS ON AND OFF WITH A MAGNET) WAS OFF. ADD'L INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 40 YR EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7434A| EXPLANTED:| EXTENSION: MODEL 7489| LEAD: MODEL 3487A