BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2961563 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02631
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 28, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S DEVICE STOPPED WORKING TWO WEEKS AGO. WHEN SHE TURNED THE DEVICE ON SHE FELT STIMULATION IN HER BACK INSTEAD OF FEELING STIMULATION IN HER LEFT LEG AND FOOT WHERE IT SHOULD BE. AT 4.10 AMPS SHE HAD TO TURN THE STIMULATION DOWN BECAUSE SHE COULD NOT WALK OR CONTROL HER FOOT AND LEG. THE DEVICE WAS NOT HELPING AND COULD BARELY FEEL STIMULATION WHEN SET AT 4.30 AMPS. IT WAS NOTED THAT SHE FELL ON THE SNOW AND ICE ABOUT FOUR DAYS AFTER IMPLANT SURGERY. SHE LANDED ON HER TAILBONE AND IT WAS A HARD FALL. THE FALL WAS NOT REPORTED TO HER PHYSICIAN NOR HAS SHE HAD HER DEVICE CHECKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65657 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1