BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2830974 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10216
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 17, 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

    PRODUCT ID: 74002, LOT#: N233270, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER; PRODUCT ID: 3777-60, LOT#: V745889008, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID: 3777-60, LOT#: V745889007, 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 HIGH IMPEDANCE MEASUREMENTS (>20,000 OHMS) WERE SEEN ON ELECTRODES #4, 5, AND 6 OF THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE PATIENT FELT STIMULATION IN THEIR RIGHT LEG BUT NOT THEIR LEFT LEG. THERE WAS NO REPORT OF FALLS OR A CHANGE IN THE PATIENT'S ACTIVITIES SINCE IMPLANTATION. THE PATIENT WAS PROGRAMMED WITH ELECTRODES 4 AND 6 BUT DID NOT FEEL STIMULATION. THE COMPANY REPRESENTATIVE CHANGED THE PROGRAM TO MAKE ELECTRODE #7 NEGATIVE AND THE PATIENT WAS ABLE TO FEEL SOME STIMULATION. FOLLOW UP INFORMATION REPORTED THAT IMPEDANCE CHECKS, X-RAYS, AND SEVERAL REPROGRAMMING ATTEMPTS WERE PERFORMED WITH THE RESULT THAT THE PATIENT DID GET SOME STIMULATION (WITH THE "BOTTOM ELECTRODE") WHICH GAVE THEM SOME THERAPEUTIC RELIEF UNTIL THE PHYSICIAN DETERMINES IF ANY FURTHER INTERVENTIONS ARE NEEDED. THE CAUSE OF THE EVENT WAS REPORTED AS UNDETERMINED. THE PATIENT WAS REPORTED AS DOING WELL AND WAS CONTENT WITH THE LIMITED STIMULATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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