BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2994348 · Received March 8, 2013

    Report

    Report Number
    3004209178-2013-03485
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 15, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OVERSTIMULATION SENSATION. THE PATIENT DID NOT HAVE STIMULATION "AT ALL" BUT IF HE MOVED HIS HEAD OR MADE A SMALL CHANGE IN HEAD POSITION OR BODY POSITION HE WOULD GET "EXCESSIVE" STIMULATION. IT WAS ALSO REPORTED THAT LOW OUT OF RANGE IMPEDANCE VALUE WAS SEEN. ELECTRODES 1 AND 10 WERE SHOWING <(><<)> 50 OHMS. WHEN THE PATIENT MOVED HIS HEAD SLIGHTLY FORWARD, HE LOST THE STIMULATION AND THE IMPEDANCE VALUE ON THE ELECTRODE PAIR 1/10 WAS SHOWING "FINE" WITH THE RANGE OF 558-855 OHMS. WHEN THE PATIENT MOVED HIS HEAD BACK ABOUT 1/4 INCH, HE FELT INTENSE STIMULATION AND 1/10 PAIR SHOWED <(><<)> 50 OHMS AGAIN. AT THE TIME OF THE REPORT PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROGRAMMED TO USE ELECTRODES 10, 11, 12, AND 13. ELECTRODE 10 WAS THEN REMOVED FROM THE PROGRAMMING. THE PATIENT COULD FEEL STIMULATION IN "BILATERAL LEGS" WITH ELECTRODES 11, 12, AND 13. HE WAS FEELING STIMULATION CHANGES IN INTENSITY WITH ARCHING HIS BACK AND FLEXING AROUND. IT WAS STATED THAT THIS WAS TO BE EXPECTED AND THAT FINE TUNING THE PROGRAMMING WOULD BE CONTINUED. FOUR DAYS LATER IT WAS STATED THAT PROGRAMMING AROUND THE "BAD" ELECTRODES WAS PERFORMED AS AN INTERVENTION. AT THE TIME OF REPROGRAMMING, THE PATIENT SEEMED "HAPPY." NO FURTHER FOLLOW UP WAS DONE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98703 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1