BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3002286 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03650
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 20, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ELECTRODE 15 HAD IMPEDANCES GREATER THAN 10,000 BUT IT WAS NOT BEING USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED 'A LOSS OF THERAPEUTIC EFFECT.' IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED 'MORE HEADACHES' AND THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS 'NOT WORKING TO CONTROL THEM AT ALL.' IT WAS NOTED THAT 'THE INCREASE IN MIGRAINES MAY HAVE BEEN DUE TO STRESS.' IT WAS ALSO REPORTED THAT THE INS WAS 'TURNING OFF.' THE FIRST TIME THAT STIMULATION TURNED OFF WAS REPORTED AS HAVING OCCURRED DURING '(B)(6) 2013.' THE STIMULATION WAS ALSO REPORTED TO HAVE SHUT OFF 'A FEW TIMES THE LAST COUPLE OF WEEKS' PRIOR TO REPORT. THE PATIENT STATED THAT 'THE PROGRAMMER SHOWS STIMULATION IS OFF WHEN SHE FEELS STIMULATION TURN OFF.' IMPEDANCE TESTING REVEALED THAT THE 'MEASUREMENTS ARE NORMAL.' IT WAS NOTED THAT THE PATIENT HAD ALLOWED THE IMPLANT BATTERY TO GET 'VERY LOW A COUPLE OF TIMES.' THE INS WAS REPROGRAMMED IN AN ATTEMPT 'TO GET BETTER COVERAGE ON ONE SIDE.' THE PATIENT WAS REDIRECTED TO HER HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104647 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