BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3381856 · Received October 2, 2013

    Report

    Report Number
    3004209178-2013-17331
    Event Type
    Malfunction
    Date Received
    October 2, 2013
    Report Date
    September 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT PRODUCT ID 377775, LOT# V010569, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD, PRODUCT ID: 377775, LOT# V010569, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATOR WAS TURNING OFF. THIS STARTED OCCURRING EARLIER THIS YEAR. THE PATIENT WOULD STOP FEELING STIMULATION AND THEN CHECK WITH THE PROGRAMMER TO FIND THAT THE STIMULATOR WAS OFF. IT DID NOT CORRELATE WITH THE CHARGE LEVEL. THE PATIENT CHARGED REGULARLY ONCE A WEEK. THE PATIENT HAD SOME FALLS/TRAUMA BUT IT WAS NOT KNOWN IF IT CORRELATED WITH THE DEVICE TURNING OFF. IMPEDANCES READINGS RANGED FROM 2471 OHMS TO GREATER THAN 3600 OHMS ON ELECTRODE 8. THE ELECTRODE IMPEDANCES WERE ON THE HIGHER END BUT THE THERAPY IMPEDANCE WAS IN A NORMAL RANGE. THE PATIENT WAS PROGRAMMED WITH ELECTRODES 5, 6, 7 AND 13, 14, 15. IT WAS UNKNOWN IF THE STIMULATION CHANGE WAS RELATED TO POSITION. THE PATIENT WAS ADVISED TO KEEP A LOG OF WHEN THEY FELT THE STIMULATION TURN OFF. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498612 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR