BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2775760 · Received October 8, 2012

    Report

    Report Number
    3004209178-2012-08987
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Report Date
    September 20, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-33, LOT# J0443918V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION. THE EVENT HAD BEEN ONGOING FOR ABOUT A MONTH. THE PATIENT HAD HIGH IMPEDANCES. THERE WERE NO FALLS OR TRAUMA REPORTED TO BE ASSOCIATED WITH THE LOSS OF STIMULATION. THE IMPEDANCES WERE AS FOLLOWS: 01 >10000, 02 >10000, 03 887, 12 >10000, 13 >10000, 23 979. THE PATIENT WAS PROGRAMMED ON 0 NEGATIVE, 3 POSITIVE WHEN SHE CAME IN WITH NO STIMULATION. SHE WAS REPROGRAMMED WITH 0 POSITIVE AND 3 NEGATIVE AND SHE FELT ABDOMINAL STIMULATION. THE PROGRAMMING WAS CHANGED TO 3 NEGATIVE, 2 POSITIVE AND THE PATIENT WAS GETTING GOOD COVERAGE AND FEEL STIMULATION BETWEEN 4 TO 5 VOLTS, 450US, 70 HZ RATE AND GROUP IMPEDANCE OF 864OHMS, 5.624MA. THE PATIENT WAS PROGRAMMED AROUND THE AFFECTED ELECTRODES AND WAS SATISFIED WITH THEIR COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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