BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4102774 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17399
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-45, LOT# VA081ZT, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-45, LOT# VA04WDL, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97791, LOT# N479584, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY ABOUT A MONTH LATER BUT WAS WORKING WITH HER DOCTOR OR COMPANY REPRESENTATIVE. APPOINTMENT DATES OF (B)(6) 2014 WERE NOTED. THE PATIENT WAS CHARGING MORE THAN EXPECTED AND DID NOT HAVE ENOUGH THERAPEUTIC EFFECT. WHEN THE PATIENT WAS IMPLANTED, IT WAS FULLY CHARGED BUT ONLY LASTED TWO DAYS. THE PATIENT WAS TOLD IT SHOULD LAST A WEEK; SINCE THEN SHE HAS HAD TO CHARGE EVERY DAY AND IT USUALLY TAKES HER 3-4 HOURS. THE DEVICE WAS SET AT 5V OR 6V. YESTERDAY IT WAS FULLY CHARGED, SAW THE CHARGE COMPLETE SCREEN, AND NOW TODAY IT WAS DOWN TO 25% (LESS THAN HALF BUT LOOKED LIKE 40%). ON (B)(6) THE PATIENT WENT TO A HOSPITAL AT 9AM FOR HER SON'S SURGERY AND SHE WAS FULLY CHARGED; BY 9PM SHE BARELY HAD ANY BATTERY LEFT. WHEN THE PATIENT CHARGES SHE HAS TO LIE DOWN TO MAKE SURE SHE HAS GOOD COUPLING, SHE TRIES TO MAKE SURE SHE HAS ALL EIGHT BOXES SHADED IN. IT WAS CONFIRMED THAT THE PATIENT WAS READING THE BATTERY ICON LEVEL CORRECTLY. THE DEVICE HAS NOT GIVEN THE PATIENT RELIEF SHE WAS LOOKING FOR SINCE TIME OF IMPLANT. THE PATIENT HAS THE IMPLANT FOR HER BACK, LEGS, AND FEET. THE PATIENT HAD A HARD TIME REACHING THE PAIN IN HER RIGHT LEG AND BACK. RIDING IN THE CAR (TRAVELING BACK AFTER IMPLANT) WAS DIFFICULT. THE PATIENT COULD NOT REACH A HAPPY MEDIUM TO HELP WITH THE PAIN. THE DEVICE DOES HELP THE LEFT LEG TO A CERTAIN EXTENT. THE TRIAL WORKED REALLY WELL. WITH THE TRIAL THERE WAS ONE LEAD AND WITH THE PERMANENT IMPLANT THERE WERE THREE LEADS. SITTING WAS UNBEARABLE AND CANNOT SIT VERY LONG. THE PATIENT USES A THERAPEUTIC SCIATIC PILLOW BUT IT DOES NOT HELP MUCH. IF THE PATIENT HAS IT WHERE IT WAS SET, SOMETIMES IT MAKES HER HURT WORSE SO SHE HAS TO TURN IT DOWN. AN INFORMATION REQUEST WAS MADE, THE PATIENT'S BOOKS DID NOT HAVE HER MODEL NUMBER ON THE FRONT. THE NEXT APPOINTMENT FOR THE PATIENT WAS ON (B)(6). THE PATIENT DID NOT WANT TO HAVE TO CONTINUE CHARGING 3-4 HOURS EVERY DAY FOR THE NEXT MONTH.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED ON (B)(6) 2014 WITH A SPINAL CORD STIMULATION (SCS) AND THE ¿BATTERY WENT DEAD ON SATURDAY MORNING¿. IMPLANT NEUROSTIMULATOR (INS) BATTERY DEPLETION WAS REPORTED. IT WAS STATED ¿IT WAS GOING BAD ON ME THE NIGHT BEFORE AND THEN SATURDAY MORNING IT WENT OFF, I GUESS I WORE IT OUT TOO MUCH BECAUSE NOW ITS DEPLETED¿. THE PATIENT WAS ¿TOLD NOT TO CHARGE BECAUSE OF MY NEW INCISION BUT I AM WORRIED THAT IT WILL DAMAGE THE BATTERY¿. THE PATIENT WAS GOING TO SEE HER HEALTH CARE PROVIDER (HCP) ON WEDNESDAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FIND OUT IF ANY INTERVENTION WAS DONE AND THE PATIENT OUTCOME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT'S HEALTH CARE PROVIDER (HCP) CONFIRMED THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT TURNED ON. THE CAUSE OF THE EVENT WAS DETERMINED AND IT WAS NOT DEVICE RELATED, POOR PATIENT INPUT. REPROGRAMMING WAS PERFORMED WHICH RESOLVED THE EVENT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    A COUPLE MONTHS LATER IT WAS REPORTED THAT THE PATIENT SAW A COMPANY REPRESENTATIVE AND THE DEVICE WAS REPROGRAMMED. THE PATIENT NOW HAS TWO PROGRAMS TO USE AND WAS USING LESS VOLTAGE. THE PATIENT WAS HAVING SOME IMPROVED RELIEF WITH THE NEW PROGRAMS. IT WAS NOTICED THAT SOME OF PAIN WAS POSITIONAL. THE PAIN WAS FROM THE PATIENT'S UNDERLYING BACK PROBLEM, NOT THE STIMULATOR. THE PATIENT HAS LEARNED THAT THE LOWER VOLTAGE GIVES BETTER RELIEF AND SHE DOES NOT NEED TO CHARGE AS OFTEN. PATIENT STILL HAS PAIN BUT WAS WORSE IF THE STIMULATOR WAS NOT ON. THE PATIENT WAS ALLERGIC TO MOST PAIN MEDICATIONS BUT DOES TAKE GABAPENTIN TWICE DAILY TO SUPPLEMENT THE STIMULATOR. THE PATIENT TRULY BELIEVES IN THE DEVICE MANUFACTURER AND KNOWS THIS MAY TAKE SOME FINE TUNING TO GET IT WHERE SHE NEEDS IT. IT WAS NOTED THAT THE INSIDE BOOKLET OF THE PATIENT MANUAL, TWO PAGES FROM THE BACK READS; 97740, 2012-11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585063 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR