BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2862483 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11314
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 13, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION. THE PATIENT WAS REPROGRAMMED ON (B)(6) 2012 AND THE DEVICE WORKED WELL ON THAT DAY THROUGH THE AFTERNOON OF THE FOLLOWING DAY. THE FOLLOWING DAY, THE STIMULATION WAS TOO STRONG. THE PATIENT TURNED THE STIMULATION DOWN BUT IT WASN'T DECREASING THE STIMULATION SENSATION SO SHE TURNED IT OFF. IT WAS NOTED THAT WHEN THE PATIENT "LAY ON HER BACK OR LOOKED UP/THREW HER HEAD BACK", THE STIMULATION GOT STRONG. IT WAS ALSO REPORTED THAT THE STIMULATION WAS IN THE WRONG LOCATION, WITH STIMULATION BEING FELT IN PATIENT'S LEGS BUT NOT IN HER BACK. THE PATIENT'S BACK "HURT SO BAD SHE COULDN'T GET UP." IT WAS FURTHER NOTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT GOT "NUMBNESS, BURNING AND TINGLING" SENSATION IN HER FEET WHICH WERE INDICATED TO HAVE BEEN CAUSED BY A "NERVE IN HER COLON BEING HIT." THIS NERVE WAS HIT WHEN PATIENT WAS CONSTIPATED, WHO WAS STATED TO HAVE IRRITABLE BOWEL SYNDROME (IBS). PRIOR TO WHEN PATIENT WAS REPROGRAMMED, SHE HAD TWO DAYS WHERE HER FEET WERE "BURNING REALLY BAD"; SHE COULD FEEL THE STIMULATION BUT IT DID NOT HELP WITH THE NUMBNESS, BURNING AND TINGLING SHE FELT IN HER FEET. IT WAS ALSO REPORTED THAT THE PATIENT TURNED THE STIMULATION DOWN ON ONE OF HER PROGRAMS FROM .65V TO .55V BUT STIMULATION WAS STILL TOO STRONG. STIMULATION ON PATIENT'S OTHER PROGRAM WAS ADJUSTED DOWN BUT "2.5V WAS NOT ENOUGH AND 2.6V WAS TOO MUCH", AND PATIENT WAS STILL ONLY FEELING STIMULATION IN HER LEGS. STIMULATION ON THE PREVIOUS PROGRAM WAS ADJUSTED UP TO 1.7V AND PATIENT DID NOT FEEL STIMULATION IN HER BACK AND NO CHANGE IN STIMULATION. STIMULATION WAS REPORTED TO BE "SPEEDING UP AND SLOWING DOWN" AND PATIENT "DIDN'T REALLY LIKE THAT". ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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