BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2962326 · Received February 14, 2013

    Report

    Report Number
    9614453-2013-00502
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 1, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED OVERSTIMULATION, SHOCKING/JOLTING SENSATION, AND DYSESTHESIA INSTEAD OF PARESTHESIA. IT WAS STATED THAT THE PATIENT COULDN'T LEAVE THE STIMULATION ON MORE THAN 15 MINUTES RIGHT AFTER IMPLANTATION, BECAUSE THEY FELT "BURNING SENSATIONS" NEAR THE NEUROSTIMULATOR. THE PATIENT REPORTEDLY "ALMOST" STOPPED USING IT. IT WAS NOTED THAT TWO WEEKS PRIOR TO THE REPORT, THE PATIENT TRIED TO PUT IT ON AGAIN AND SHE HAD AN "INTENSE OVERSTIMULATION EPISODE" WHILE REACHING FOR THE RADIO IN HER CAR. SINCE THIS EVENT, THE PATIENT REPORTEDLY NO LONGER HAD A BURNING SENSATION NEAR THE NEUROSTIMULATOR, BUT THE STIMULATION WAS "VERY UNPLEASANT." IT WAS STATED THAT IT FELT "LIKE SOMEONE WAS PUTTING THOUSANDS OF NEEDLES WHERE THE STIMULATION WAS LOCATED." IT WAS NOTED THAT THE PATIENT FELT PAIN IN THEIR LEFT LEG. IMPEDANCES WERE REPORTEDLY NORMAL. PATIENT WAS ALIVE WITH NO INJURY AND NO ADVERSE EVENT. IT WAS STATED THAT THE DEVICE WAS REPROGRAMMED. ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE BURNING SENSATION THE PATIENT EXPERIENCED STOPPED WHEN THE PATIENT HAD TURNED THE STIMULATION OFF. THE DEVICE WAS OFF 'DURING A FEW WEEKS (MAYBE MONTHS)' BEFORE THE PATIENT HAD TURNED IT ON 2 WEEKS PRIOR TO INITIAL REPORT. THE PATIENT'S OVERSTIMULATION WAS IN THE AREA WHERE THE PATIENT USUALLY FEELS STIMULATION. IT WAS NOTED AN EXPLANT OF THE DEVICE WAS CANCELLED, AND THE PATIENT WAS TRYING OTHER STIMULATION PARAMETERS TO SEE IF IT WOULD 'GET BETTER.' IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65455 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1