BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3182253 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10708
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TURNED OFF HER STIMULATION BEFORE GOING SWIMMING ON THE DAY PRIOR TO REPORT. IT WAS NOTED THAT LATER THAT DAY THERE WERE THUNDERSTORMS AND THE PATIENT¿S HOUSE WAS ¿STRUCK.¿ IT WAS FURTHER NOTED THAT THIS ¿FRIED THE TV, WHICH WAS ABOUT 15-20 FEET AWAY FROM THE PATIENT.¿ IT WAS NOTED THAT THE PATIENT WAS NOT ABLE TO TURN HER STIMULATION ON AND WAS NOT ABLE TO CHARGE AFTER THIS OCCURRED. IT WAS NOTED THAT ON THE DAY OF REPORT THERE WAS NO TELEMETRY WITH IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) AND IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE INS INDICATED THAT IT WAS DISCHARGED. IT WAS FURTHER NOTED THAT THE PATIENT WAS NOT EVEN GETTING SCREEN WITH COUPLING BOXES. REPORTEDLY, THE CALLER TRIED ANOTHER INSR TO MAKE SURE INSR WAS NOT AN ISSUE, AND WITH THE NEW INSR, THE CALLER WAS ABLE TO GET COUPLING BOXES, BUT NONE OF THEM WERE FILLED. IT WAS NOTED THAT THE PATIENTS INS WAS ¿IN THE MIDDLE OF HER TUSH¿ AND THAT THE PATIENT SOMETIMES HAD TROUBLE RECHARGING. IT WAS NOTED WITH FURTHER ATTEMPTS THEY WERE ABLE TO GET 2 ¿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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283838 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