BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3011377 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03931
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    March 6, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT'S IMPLANTABLE NEURO STIMULATOR (INS) HAD BEEN SHUT OFF FOR CLOSE TO A YEAR BECAUSE IT HAD NOT BEEN HELPING WITH THE PATIENT'S PAIN. IT WAS NOTED THE DEVICE TOOK CARE OF 40 TO 50% OF THEIR PAIN AT FIRST. PATIENT HAD NOT BEEN ABLE TO MOVE FOR SEVERAL HOURS AFTER GETTING UP IN THE MORNING AND COULD NOT GET UP AND MOVE AROUND THE HOUSE. THE DEVICE HAD WORKED FOR 5 TO 6 MONTHS POST OPERATIVELY BUT THE PATIENT HAD "PROBLEMS EVER SINCE". IT WAS NOTED THE PATIENT HAD A FALL 2 TO 5 MONTHS AFTER THEIR IMPLANT. DEVICE WAS RECENTLY CHECKED AND X-RAYS SHOWED THE LEAD HAD MOVED. PATIENT BELIEVED THE LEAD MOVEMENT WAS DUE TO THEIR PREVIOUS FALL. IT WAS NOTED WHEN THE PATIENT HAD STIMULATION ON IT WAS FELT 75% IN THEIR STOMACH. FOLLOW UP REPORTED IMPEDANCES WERE CHECKED BUT THE RESULTS WERE UNKNOWN. NO INTERVENTIONS HAVE BEEN TAKEN OR PLANNED. IT WAS NOTED PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY BUT IT WAS NOTED IT WAS BELIEVED THE PATIENT WAS GOING TO SEE THEIR IMPLANTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113276 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 00052 YR