BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4872342 · Received June 26, 2015

    Report

    Report Number
    3004209178-2015-12348
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    May 23, 2014
    Report Date
    September 20, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 MEDICAL PRODUCTS: PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED:(B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED:(B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT STATING THAT THEY WERE IN PAIN AND COULD NEVER ADJUST THE STIMULATOR TO GET IT QUITE RIGHT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT SHE HAD PAIN ALL OVER. THE CONSUMER HAD A CONDITION THAT CAUSED HER PAIN IF SHE WAS NOT LYING DOWN. IF THE CONSUMER SAT OR STOOD FOR ANY AMOUNT OF TIME SHE WOULD BE IN PAIN. IT WAS NOTED THAT THIS WAS NOT RELATED TO HER STIMULATOR DEVICE; HOWEVER, IT WAS ALSO NOTED THAT STIMULATION DID NOT HELP WHEN SHE WAS SITTING OR STANDING SINCE IMPLANT. THE CONSUMER STATED THAT SHE HAD AN MRI RECENTLY TO SEE IF SHE HAD ANY SCAR TISSUE CAUSING HER PAIN AND THE DOCTOR TOLD HER PAIN WAS CAUSED BY AN ISSUE WITH HER VERTEBRAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING AN MRI, AND THE MRI WAS UNRELATED TO THE DEVICE OR THERAPY. SINCE IMPLANT, THE THERAPY HAD NOT HELPED THE PATIENT WITH SITTING OR STANDING. IT WAS NOTED THAT THE PATIENT WAS DIAGNOSED WITH CANCER BEFORE IMPLANT, AND THE PATIENT WAS ALSO DIAGNOSED WITH A PROBLEM WITH THE RIGHT KIDNEY ON THE WEEK OF FOLLOW UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN BECAUSE SCAR TISSUE WAS GROWING INTO HER NERVES CAUSING PAIN. THE PATIENT HAD WORSENING PAIN AND MUST LIE FLAT. THE PATIENT HAD TO LAY FLAT ALL THE TIME BECAUSE OF HER PAIN. WHEN THE PATIENT DRIVES SHE HAD TO LIE FLAT ON THE BACK SEAT. PRIOR TO IMPLANT THE PATIENT WAS ABLE TO SIT UP FOR A LITTLE WHILE. GRADUALLY SINCE IMPLANT THE PATIENT HAD INCREASED PAIN AND WAS NO LONGER ABLE TO SIT UP A LITTLE BIT. JUST TO GET INTO THE CHAIR OR STAND AND GO OVER TO THE COMMODE WAS VERY PAINFUL. THE PATIENT STATED WHEN THE PAIN GOT GREATER THE MACHINE GETS TO BEATING SO HARD IT MAKES HER THINK SHE WILL HAVE A HEART ATTACK. THE PATIENT HAD UNCOMFORTABLE STIMULATION WHEN TURNED UP TOO HIGH. THE STIMULATION WENT FAST WHEN SHE SAT UP OR TRIED TO GET UP. IT FELT LIKE A ¿BUNNY RABBIT TAPPING ITS FOOT¿ SO FAST TRYING TO HELP THE PAIN BUT IT WAS NOT HELPING THE PAIN WHEN SHE WAS UP. IT WAS BETTER TO TURN IT OFF. THE PATIENT STARTED FEELING STIMULATION TOO FAST AS SOON AS SHE CAME HOME FROM THE LAST TIME SHE HAD IT ADJUSTED AT THE DOCTOR¿S OFFICE. THE PATIENT HAD TO TURN IT OFF ON THE WAY HOME. THE PATIENT DID NOT KEEP IT ON THAT MUCH BUT WHEN SHE USED IT ¿IT WAS GOOD FOR THE MASSAGE OF IT IS COMFORTING.¿ THE PATIENT STATED THAT THE DEVICE HELPED THE PATIENT WHEN SHE WENT TO BED AT NIGHT AND IT HELPED THE PATIENT TO RELAX A LITTLE BIT. THE PATIENT LAYS FLAT AND THE DEVICE HELPS WHEN SHE IS LAYING FLAT AND DOES NOT GO FAST. THE DEVICE NEVER HELPED WHEN THE PATIENT WAS STANDING. THE DEVICE DID NOT HELP BECAUSE THE SCAR TISSUE WAS SO GREAT. THE PATIENT WAS TOLD THAT THE SCAR TISSUE WAS GROWING INTO HER NERVE PROBABLY 6 MONTHS PRIOR TO REPORT. THE PATIENT STATED THAT THE PAIN WAS REALLY GREAT IF ¿YOU PUT YOUR HANDS ON YOUR HIP AND IF YOU FOLLOW YOUR BUTT AREA AND CIRCLE AROUND AND GO UP TO THE HIP ON THE OTHER SIDE AND THEN DOWN ESPECIALLY THE OUTSIDE PART OF THEIR LEGS AND INTO THEIR FEET AND IT CAME BACK UP ABOUT TO THE KNEES. THE PATIENT WAS NOT FEELING IT SO MUCH FROM THEIR KNEES UP TO THEIR PRIVATE AREA ON THE INSIDE JUST THE OUTSIDE. THE PATIENT HAD BEEN IN A COUPLE OF TIME FOR ADJUSTMENTS TO STIMULATION BUT SHE WAS IN SO MUCH PAIN FROM THE TRAVEL THAT SHE COULD NOT TELL IF THE STIMULATION CHANGES WERE HELPING OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415755 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR