BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3977698 · Received August 4, 2014

    Report

    Report Number
    3004209178-2014-13927
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    July 11, 2014
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-39, LOT # N321956, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 399960, LOT # V961945, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT # N325932, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3550-P4, LOT # N324513, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STILL HAD A LOT OF BREAK THROUGH PAIN- BURNING AND STINGING. IT WAS REPORTED THE PATIENT¿S BREAKTHROUGH PAIN LEVEL WAS VERY HIGH. THE PATIENT THERAPY REPORTEDLY NEVER HELPED HER ARMS, AND SHE WAS NOT HAVING PAIN IN HER ARMS BEFORE. THE PATIENT HAD NUMBNESS AND TINGLING IN HER LEFT LEG AND RIGHT ARM. THE PATIENT HAD PAIN COMING ACROSS THE ARM, DESCRIBED AS ¿EXCRUCIATING.¿ THIS REPORTEDLY STARTED THIS YEAR, A FEW MONTHS AGO. THE HEALTH CARE PROVIDER (HCP) GAVE THE PATIENT ¿SHOTS.¿ THE PATIENT SOMETIMES FELT THAT SHE HAD THE PAIN 3-4 DAYS IN A ROW WHERE SHE FELT THE STIMULATOR WAS NOT DOING ANYTHING FOR HER PAIN. IT WAS NOTED THAT SHE HAD BREAKTHROUGH PAIN AND WONDERED WHY SHE WAS HURTING SO BAD, CHECKED HER STIMULATOR WITH HER PATIENT PROGRAMMER (PP) AND REALIZED THAT HER THERAPY TURNED ITSELF OFF SOMEHOW. IT WAS NOTED THE PATIENT TURNED IT ON AND STARTED FEELING BETTER. THE PATIENT WAS ON ORAL NARCOTICS (OXYCONTIN) AND QUIT 2 MONTHS AGO. THE PAIN BECAME WORSE AFTER SHE QUIT OXYCONTIN. THE PATIENT WAS HURTING WORSE BECAUSE SHE DIDN¿T TAKE ANY PILLS. THE PATIENT REPORTEDLY GOT NAUSEATED VERY EASILY. THE PATIENT¿S BATTERY WENT DEAD THIS YEAR BECAUSE THE PATIENT FORGOT TO CHARGE, AND IT HAD HAPPENED 2-3 TIMES WHEN SHE FIRST GOT IT. THE PATIENT DID NOT HAVE TO GO TO THE HCP TO ¿JUMP START IT¿ AND IT SHOWED A SCREEN WITH THE BATTERY LEVEL AND NO LIGHTNING BOLT. THE PATIENT REPORTEDLY DID NOT FEEL PULSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454000 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