BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR 37021 RX1 EXTERNAL

    MDR report key: 3833300 · Received May 27, 2014

    Report

    Report Number
    3007566237-2014-01438
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TRIAL TEST DONE ¿A COUPLE OF THREE WEEKS AGO.¿ IT WAS NOTED THAT THE PROGRAM THAT THE PATIENT WAS GIVEN WAS NOT A GOOD PROGRAM. IT WAS SUPPOSED TO BE THROUGH THE BACK IN THE HIP LINE STRAIT ACROSS AND DOWN BOTH LEGS. IT WAS NOTED THAT THE PATIENT DID THE TRIAL ON (B)(6) 2014. IT WAS NOTED THAT THE DOCTOR DID NOT GET ONE OF THE WIRES IN THE RIGHT PLACE. IT WAS NOTED THAT WHILE THE PATIENT WAS GETTING PROGRAMMED THE STIMULATION WAS TURNED UP SO HIGH AROUND THE RIGHT RIB CAGE THE PATIENT DOUBLED OVER AND SCREAMED AND TOLD THEM TO STOP. IT WAS NOTED THAT IT HAPPENED A SECOND TIME. IT WAS NOTED THAT WHEN EVERYTHING WAS FINISHED THE STIMULATION WAS AROUND THE PATIENT¿S ANKLE AND RIB CAGE AND THE PATIENT HAS NO PAIN THERE. IT WAS NOTED THAT THE PATIENT WAS GOING TO BE IMPLANTED WITH A PERMANENT IMPLANT ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT WAS IN A LOT OF PAIN AND WAS HOPING THAT THIS WOULD HELP. IT WAS NOTED THAT THE X-RAYS FOR THE TRIAL SHOWED THE LEAD WAS PLACED ABOVE THE SPINAL PROCESS. IT WAS NOTED THAT WAS THE LEFT LEAD. IT WAS NOTED THAT THE RIGHT LEAD WAS PLACED PROPERLY. IT WAS NOTED THAT THERE WAS MINIMAL CONTROL AT THE RIGHT LOWER BACK ¿BUT WHEN THE PATIENT WAS AT (B)(6), KNOW HOW FAR TO WALK BEFORE THE PATIENT HAD TO STOP AND REST BECAUSE OF THE PAIN. IT WAS NOTED THAT THE PATIENT HAD TO GO AND ASK HER HUSBAND TO GET HER A WHEELCHAIR BECAUSE SHE COULD NOT MOVE. IT WAS NOTED THAT AT THAT POINT THE PAIN GOT SO INTENSE THE PATIENT TURNED THE UNIT UP AS HIGH AS SHE COULD STAND IT. IT WAS NOTED THAT DID NOT FIX THE PAIN ON THE LEFT HAND SIDE. IT WAS NOTED THAT IT DID GIVE PAINFUL STIMULATION ON THE LEFT HAND SIDE RIB CAGE. IT WAS NOTED THAT IT MADE THE PATIENT¿S ANKLE WANT TO TWIST MEDIALLY SO THE PATIENT FELT SHE WAS WALKING ON THE OUTSIDE OF HER FOOT BUT WASN¿T. IT WAS NOTED THAT IT FELT LIKE IT WAS TURNING NUMB AND WALKING ON THE EDGE OF FOOT. IT WAS NOTED THAT THERE WAS TERRIBLE PAIN AROUND HER RIB CAGE. IT WAS NOTED THAT THIS WAS WAY PAST THE SECURITY GATES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT GOT 50 PERCENT REDUCTION OF HER SYMPTOMS. IT WAS NOTED THAT THE LEAD WAS PLACED ON THE SPINOUS PROCESS. IT WAS NOTED THAT THE DOCTOR KNEW THAT IT WAS PLACED IMPROPERLY BECAUSE IT WAS ON THE SPINOUS PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311551 STIMULATOR 37021 RX1 EXTERNAL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37021

    Patients

    Seq Age Sex Outcome Treatment
    1