BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3565411 · Received January 9, 2014

    Report

    Report Number
    3004209178-2014-00412
    Event Type
    Malfunction
    Date Received
    January 9, 2014
    Date of Event
    November 25, 2013
    Report Date
    December 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A-33, LOT # V013723, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS ON VACATION FOR THANKSGIVING APPROXIMATELY ONE MONTH PRIOR TO REPORT THE ¿FELT LIKE STIMULATION CAME ON.¿ IT WAS REPORTED THE PATIENT FELT A ¿PULSATING FEELING¿ IN THEIR WHOLE UPPER BODY. IT WAS NOTED THAT AT FIRST THE PATIENT THOUGHT IT WAS A PINCHED NERVE IN THEIR NECK BUT IT FELT LIKE ¿THEIR FINGER WAS IN AN ELECTRICAL SOCKET.¿ IT WAS FURTHER REPORTED THE STIMULATION STAYED ON FOR THEIR WHOLE VACATION. IT WAS NOTED IT WAS HARD FOR THE PATIENT TO DRIVE BECAUSE THEY WOULD GET ZAPPED EVERY TIME THEY MOVED. IT WAS NOTED THAT (B)(6) 2013, THE PATIENT WOKE UP AND FELT AS THOUGH THE STIMULATION HAD TURNED OFF. IT WAS REPORTED THAT ON THE DAY OF THE REPORT THE PATIENT WAS SITTING IN A CHAIR AND FELT LIKE THE STIMULATION TURNED ON AGAIN. IT WAS REPORTED THE PATIENT WAS ABLE TO TURN THE STIMULATION UP AND DOWN USING THEIR PATIENT PROGRAMMER AND TURNED THEIR STIMULATION OFF. IT WAS REPORTED THE PATIENT WAS ON MILD PAIN MEDICATIONS. INFORMATION OMITTED FOR RELATED EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17489 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR