BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3193188 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10971
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 4, 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 PRODUCTS: 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 3550-39, LOT# N322204, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 355531, LOT# N334054, IMPLANTED: (B)(6) 2012, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF STIMULATION. THERE WAS A LACK OF POSITIONS SHOWING ON THE PATIENT PROGRAMMER (PP). SHE NOTICED A CHANGE IN THE PP ON (B)(6) 2013. SHE TURNED THE STIMULATION OFF BEFORE GOING SWIMMING AND WHEN SHE WENT TO TURN THE STIMULATION BACK ON AFTER SWIMMING THERE WAS A CHANGE IN THE SCREEN AS WELL AS NOT FEELING ANY STIMULATION WITH THAT GROUP. SHE WAS USING GROUP A WHICH HAS THE ADAPTIVE STIM (AS) ENABLED. GROUP A HAS DEFINED VOLTAGES FOR EACH POSITION. GROUP C WAS A MANUAL GROUP. SHE NOTICED THE LACK OF POSITIONS ON THE PP 2-3 TIMES OVER THE PAST YEAR BUT WAS UNABLE TO REMEMBER WHETHER SHE HAD THE STIMULATION ON OR OFF DURING THE EVENTS. ON (B)(6) 2013 A SHORT ¿PRM¿ WAS PERFORMED AND THE POSITIONS SHOWED ON THE PP AGAIN BUT WERE INCORRECT IN THAT THE PATIENT WAS SITTING IN CHAIR AND PP SHOWED LYING POSITION. WHEN SYNCED UP AGAIN WITH THE PATIENT SITTING, THE PP SHOWED TRANSITION ZONE. WHEN THE DEVICE WAS REORIENTED AND VOLTAGES, POSITIONS WERE REDEFINED; THE VOLTAGES WERE PICKED UP APPROPRIATELY. THE PATIENT WAS FEELING STIMULATION AGAIN. ABOUT A WEEK LATER THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. AFTER HER (B)(6) 2013 APPOINTMENT OF HAVING HER DEVICE REPROGRAMMED AND AS SETTINGS RESET, SHE HAS BEEN HAVING MORE PROBLEMS. HER DEVICE WAS NOT READING THE POSITION. THERE WAS ONLY AN A ON THE PROGRAMMER BOX ON THE SCREEN INSTEAD OF NORMALLY IN THE CORNER. SHE WAS SITTING UPRIGHT AND THE POSITION WAS NOT REGISTERED. SHE WAS TOLD TO KEEP AN EYE ON THE DEVICE AND KEEP TRACK OF HER ISSUES. ANOTHER FOLLOW UP APPOINTMENT WAS SCHEDULED FOR (B)(6) 2013. IT WAS THOUGHT THAT HER STIMULATION WORKED WELL AFTER DEVICE REORIENTATION. IT WAS ALSO MENTIONED THAT SHE WALKED INTO A RESTAURANT FOR LUNCH AND WAS SHOCKED BY THE DEVICE. SHE CHECKED THE DEVICE BY PRESSING THE SYNC BUTTON AND IT SAID SHE WAS LYING DOWN NOT WALKING. SHE SHUT THE STIMULATION OFF AND WHEN SHE TURNED BACK ON THE PP, IT SAID SHE WAS UPRIGHT BUT WAS SITTING AT THE TABLE. SHE THEN FELT A CHANGE IN STIMULATION AND THE PP SAID SHE WAS LYING ON HER STOMACH. WHEN SHE LIES ON HER LEFT SIDE THE PP SAYS LYING ON RIGHT SIDE AND VICE VERSA. SHE WAS ON CRUTCHES AND WHEN THE DEVICE CHANGES AND SHOCKS HER IT CAUSES HER TO FALL. WHEN SHE CHANGES THE PROGRAM A TO PROGRAM C SHE DOES NOT FEEL STIMULATION UNLESS SHE INCREASES PAST 8.0 BUT THEN THE STIMULATION WAS NOT COMFORTABLE. IT WAS NOTED THAT PROGRAM C DOES NOT USE THE AS FEATURE. THESE ISSUES HAVE BEEN HAPPENING FOR SEVERAL WEEKS. THE NEXT DAY ON (B)(6) 2013 IT WAS LATER REPORTED THAT SHE EXPERIENCED AN OVERSTIMULATION SENSATION. OUT OF THE BLUE THE AMPLITUDE GOES REALLY HIGH. SHE WAS ON CRUTCHES AND SOMETIMES WHEN THE AMPLITUDE INCREASES WHEN THEY ARE MID-STEP AND THEN SHE CANNOT GET HER FOOT DOWN SO SHE ENDS UP FALLING. GROUP B WAS ALSO A MANUAL PROGRAM. WHEN SHE STANDS THE DEVICE DETECTS UPRIGHT. IT WAS NOTED THAT HER DEVICE WAS IMPLANTED IN THE STOMACH ON THE RIGHT SIDE. SHE DID NOT FEEL THAT THE DEVICE MOVED WHEN GOING FROM STANDING TO SITTING. SHE DOES HAVE TO SLOUCH WHEN SITTING. HER DEVICE WAS READJUSTED AND THEN DETECTED UPRIGHT WHEN SITTING AND STANDING. THE AMPLITUDES FOR ALL POSITIONS WERE REDEFINED. THE AS WAS TESTED TO MAKE SURE IT WAS COMFORTABLE FOR HER. A COUPLE WEEKS LATER IT WAS CONFIRMED THAT THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY. SHE HAS NOT HAD ANY PROBLEMS SINCE HER DEVICE WAS REPROGRAMMED AND REORIENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294418 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 00035 YR