BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 8051751 · Received November 8, 2018

    Report

    Report Number
    3004209178-2018-24996
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    November 5, 2018
    Report Date
    November 8, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT ALL OF A SUDDEN ON (B)(6) 2018, THE PATIENT COULD NO LONGER FEEL THE TINGLING IN THEIR RIGHT LEG WHEN THEY WERE TRYING TO ADJUST PROGRAMMING. THE STIMULATION WAS NOT AS STRONG AS IT USED TO BE AND THEY WOULD HAVE TO TURN THE STIMULATION UP VERY HIGH IN ORDER TO FEEL THE TINGLING IN THEIR RIGHT LEG. IT WAS EXPLAINED THAT THE IMPLANT WAS IMPLANTED FOR THE PATIENT'S BACK AND STIMULATION GOES DOWN THEIR LEGS. THE PATIENT'S BACK HAS ALWAYS HURT THEM; SOMETIMES IT WOULD HURT A LOT AND SOMETIMES IT WOULD NOT HURT. DURING THE CALL, THE PATIENT WAS USING GROUP A, AND WANTED TO TRY ONE OF THEIR OTHER GROUPS. THEY TRIED CHANGING TO ANOTHER GROUP BUT ENDED UP FEELING STIMULATION IN THEIR STOMACH TO THEY SWITCHED BACK TO GROUP A. THE PATIENT WAS GOING TO TRY THE OTHER GROUPS AND ADJUST STIMULATION IN EACH PROGRAM. THE PATIENT CALLED BACK THE FOLLOWING DAY ON (B)(6) 2018, AND REPORTED THAT NONE OF THEIR PROGRAMMED SETTINGS RESOLVED THE LOSS OF STIMULATION AND THEIR BACK PAIN. THE PATIENT WANTED THE STIMULATION TO GO DOWN BOTH OF THEIR LEGS AND TO THEIR BACK BUT THEY COULD ONLY FEEL IT IN THEIR RIGHT LEG. THEY ALSO REPORTED THAT PRIOR TO THE CHANGES THEY MADE ON NOVEMBER 5, 2018, THEY WERE ABLE TO FEEL STIMULATION AT 3.5 VOLTS (V), BUT NOW THEY HAD TO INCREASE THE STIMULATION TO 4.5 V TO FEEL STIMULATION. IT WAS ALSO REPORTED THAT THE INS DEPLETED BEFORE THE END OF THE DAY, WHEN USUALLY IT WOULD TAKE A WEEK TO DEPLETE. THE PATIENT DID NOT KNOW WHICH PROGRAM THEY HAD BEEN USING PRIOR TO THE CHANGES MADE ON (B)(6) 2018. THEY HAD BEEN MESSING AROUND WITH THEIR PROGRAMMER AND COULD NOT REMEMBER WHAT CHANGES THEY HAD MADE. IT WAS ALSO NOTED THAT THERE WERE NO FALLS OR TRAUMA THAT COULD HAVE CONTRIBUTED TO THIS EVENT. IT WAS REVIEWED WITH THE PATIENT THAT DIFFERENT GROUPS HAVE DIFFERENT PROGRAMMED SETTINGS, AND THAT THE INS CHARGE CAN BE AFFECTED DIFFERENTLY BASED ON THOSE SETTINGS. THEY WERE REDIRECTED TO THEIR DOCTOR FOR REPROGRAMMING AND TO DETERMINE WHY THE INS WAS DEPLETING MORE QUICKLY NOW. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889950 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR