BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2914511 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00581
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 26, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377860, LOT# V020591, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD SCHEDULED AN APPOINTMENT WITH A HEALTH CARE PROVIDER ON (B)(6) 2013. THE PATIENT WAS GOING TO HAVE ADDITIONAL X-RAYS. IT WAS NOTED STIMULATION FROM THE DEVICE WAS HELPING TO CONTROL THE PAIN "WITH RECHARGING." THE DEVICE WAS "CATCHING" THE LEFT RIB CAGE AND LEFT HIP SINCE LAST REPORT. THE STIMULATION "CAME ALONG WITH IT" AND THE PATIENT WOULD GET AN "EXTRA TINGLE LIKE THE 9V BATTERY ZAP" OUTSIDE THE HIP BACK CHEST AREA RANDOMLY AND INTERMITTENTLY. THE PATIENT WAS SEEKING TO GET THE DEVICE REPROGRAMMED. IT WAS REPORTED THAT "SOMETHING IS GOING TO HAVE TO GET SOMETHING DONE" AND THE PATIENT WAS WORRIED ABOUT MULTIPLE SURGERIES. NO SURGERIES OR INTERVENTIONS WERE REPORTED TO BE SCHEDULED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S 'SPINE SHIFTED 2 INCHES TO THE LEFT AND THE CENTER LINE TO RIB CAGE OF THE LEFT' ABOUT 2.5 MONTHS PRIOR TO THE REPORT. THE PATIENT FELT STIMULATION IN HIS HIP, AND UPPER CHEST CAVITY DOWN TO HIS KNEE, AND THAT WAS REPORTED TO BE FINE. HOWEVER, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS RUBBING AGAINST THE PATIENT'S HIP BONE. THE REPORTER STATED THAT THE PATIENT GOT 'RANDOM, INTERMITTENT JOLTS OF ELECTRICAL STATIC CHARGES LIKE A 9V BATTERY THAT ONE COULD ZAP THEIR TONGUE WITH,' ON HIS FINGER TIP. THE PATIENT STILL FELT STIMULATION EVEN WITH STIMULATION OFF, BUT THE PATIENT HAD TO KEEP STIMULATION HIGH TO COMPENSATE FOR HIS PAIN. THE REPORTER INDICATED THAT THE PATIENT WAS DIRECTED BY HIS HEALTHCARE PROVIDER (HCP) TO SEE A PSYCHIATRIST FOR EVALUATION ON (B)(6) 2013 AND WAS SCHEDULED FOR SURGERY AFTER THE FIRST OF THE YEAR. APPROXIMATELY 3 WEEKS LATER, IT WAS FURTHER REPORTED THAT THE PATIENT'S 'BACK SHIFTED LIKE OSTEOPOROSIS AND DROPPED 3 INCHES IN HEIGHT AND 3 DEGREES OFF' ON AN X-RAY TAKEN AT HIS HCP'S OFFICE. THE PATIENT HAD BECOME PHYSICALLY SHORTER. THE PATIENT 'WAS BENT OVER BECAUSE EVERYTHING WAS PUSHED AND HAD STRETCHED HIS MUSCLE AND GONE THAT WAY.' AS A RESULT, IT WAS HARD TO WALK. THE REPORTER STATED THAT WHEN THE PATIENT LOOKED AT HIMSELF IN THE MIRROR, 'HE COULD SEE A DISTINCTIVE CURVATURE, FROM RIGHT TO LEFT, LIKE A FISH HOOK.' IT WAS INDICATED THAT THE PATIENT ALSO EXPERIENCED A LOSS OF THERAPEUTIC EFFECT BUT WAS FEELING STIMULATION. THE PATIENT WAS REPORTED TO BE IN PAIN AND WAS ON MEDICATION. HOWEVER, IT WAS ALSO NOTED THAT THE PATIENT'S DEVICE WORKED, AND IF THE PATIENT DIDN'T HAVE THE DEVICE, HIS PAIN WOULD BE '30 TIMES MORE PAINFUL.' IT WAS INDICATED THAT TWO TO THREE WEEKS PRIOR TO THE REPORT, THE PATIENT WENT TO THE EMERGENCY ROOM FOR PAIN IN THE BACK AREA. THE PATIENT HAD INJECTIONS WHILE ON MEDICATION AND WAS GIVEN THE WRONG MEDICATION WITH MORPHINE. THE REPORTER STATED THAT THE PATIENT 'WENT INTO A SEMI-COMA STATE AND LOST 5 DAYS OF HIS LIFE.' THE PATIENT'S MEDICATIONS WERE REPORTED AS FOLLOWS: MORPHINE LIQUID 100MG/2ML 4 TIMES DAILY, 60 MG OF MORPHINE SULFUR TABLETS, 60 MG OF MORPHINE TABLETS, LYRICA, VYTORIN, 10MG OF FLEXALL TABLETS AND 50MG OF SAVELLA TABLETS. THE REPORTER INDICATED THAT THE PATIENT'S WIRES STARTED TO PULL/BEND ON THE X-RAYS AND WAS WORRIED 'IT WOULD PULL AWAY FROM THE SPINE.' THE WIRES WERE ALSO NOTED TO HAVE 'JUST RANDOMLY SHIFTED ON THE LOWER PART OF THE PATIENT'S BACK.' THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA PRIOR TO 2-3 MONTHS PRIOR TO THE REPORT. IT WAS STATED THAT THE HCP WHO TOOK THE X-RAYS 'COULD NOT DO ANYTHING WITH IT' BUT COULD REFER THE PATIENT TO ANOTHER HCP. THE REPORTER STATED THAT THE PATIENT'S DEVICE WOULD NEED TO BE REPLACED EVENTUALLY AND WAS SCHEDULED TO MEET HIS HCP TO DISCUSS THE BATTERY ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS "JUST" IN THE HOSPITAL AND HAD HIS BATTERY REPLACED. IT WAS NOTED THAT THE REASON THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED WAS BECAUSE IT NEEDED TO BE REPOSITIONED SO IT WAS JUST REPLACED TOO. IT WAS REPORTED THAT THE REPLACEMENT WAS DONE ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT HAD TO HAVE THE INS REPOSITIONED BECAUSE IT WAS "HITTING" HIS HIP AND RIB CAGE AND STARTED HITTING HIS HIP AND RIB CAGE "A LITTLE LESS" THAN A YEAR PRIOR TO THE REPORT. IT WAS REPORTED THAT THE CURVATURE OF HIS SPINE WAS GETTING WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20389 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention