BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3313831 · Received August 28, 2013

    Report

    Report Number
    3004209178-2013-15324
    Event Type
    Malfunction
    Date Received
    August 28, 2013
    Report Date
    August 2, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3550-29, LOT# N153073, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT HAD NOT FELT STIMULATION FOR THE PAST 4 OR 5 DAYS. IT WAS NOTED THAT THE PATIENT NORMALLY FELT STIMULATION IN HER RIGHT LEG AND FEET AND SLIGHTLY IN THE LEFT LEG. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY HAD CHARGE AND THAT THE INS WAS ON BUT THE PATIENT COULD STILL NOT FEEL STIMULATION. IT WAS NOTED THAT THE PATIENT¿S AMPLITUDE WAS SET AT 3.10 AND THAT THE PATIENT TRIED TO INCREASE HIGHER BUT WAS AFRAID STIMULATION WOULD COME ON SUDDENLY TOO STRONG. IT WAS NOTED THAT FOR THE PAST FEW MONTHS STIMULATION HAD BEEN SPORADIC AND RANDOM. IT WAS NOTED THAT THE PATIENT WOULD FEEL STIMULATION AND THEN WOULD NOT FEEL STIMULATION FOR A WHILE. IT WAS NOTED THAT A MANUFACTURING REPRESENTATIVE ADJUSTED HER THERAPY AND IT WORKED FOR A WHILE BUT THEN STARTED TO NOT WORK AGAIN. IT WAS NOTED THAT THE PATIENT HAS HAD NO FALLS OR TRAUMAS RECENTLY. ADDITIONAL INFORMATION REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422251 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR