BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3191353 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10933
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 30, 2013
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ALMOST 2 YEARS LATER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ITSELF STILL FELT VERY WARM TO THE TOUCH AND THE IT FELT LIKE HE WAS BEING BURNED BY IT. AT THE TIME, THE MANAGING PHYSICIAN TOLD THE PATIENT TO TURN IT OFF UNTIL THEY FIGURED WHAT WAS CAUSING IT. THE DEVICE HAD BEEN TURNED OFF NOW FOR ABOUT A YEAR. AT THE TIME THIS ISSUE BEGAN, THE PATIENT HAD FALLEN. THIS ISSUE WAS NEVER RESOLVED. HE FELL ABOUT 2 WEEKS AGO AGAIN. HE WAS HURT AND WANTED TO USE STIMULATION. HE TURNED IT BACK ON AND AGAIN HE FELT THE BATTERY WAS HOT AND BURNING HIM. WHEN IT WAS CHARGING, THE SIDE THAT WAS FACING HIS SPINE BURNED IN THAT AREA TOO. THE PATIENT HAD AN APPOINTMENT WITH HIS PRIMARY CARE PHYSICIAN (PCP) ON APRIL 6TH, TO BE REFERRED TO A NEW PAIN MANAGEMENT PHYSICIAN. THE PATIENT THOUGHT THAT HE JUST NEEDED TO BE PROGRAMMED. THE PATIENT DID NOT HAVE A MANAGING PHYSICIAN CURRENTLY, ONLY A PCP AND THEY WERE NOT FAMILIAR WITH THE DEVICE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION, THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET ¿BURNS,¿ AND INCREASED BASELINE PAIN. IT WAS NOTED THIS STARTED ABOUT ONE YEAR AGO. IT WAS REPORTED THE PATIENT¿S SKIN GOT RED, WARM, AND STARTED TO PEEL ¿LIKE A SUNBURN.¿ WHEN THE INS WAS ON, THE BURNING STARTED ABOUT EIGHT TO NINE HOURS LATER AND THE PATIENT COULD FEEL THE ¿HEAT ON THE OUTSIDE.¿ THE PATIENT WOULD TURN THE INS OFF FOR FOUR TO SIX HOURS AND THE INS BEGAN TO START COOLING AT THREE HOURS. IT WAS NOTED THIS OCCURRED FOLLOWING A FALL AND THE PATIENT STATED THEY FALL A LOT. IT WAS NOTED THAT THE PATIENT¿S INS HAD BEEN INTERROGATED USING A PHYSICIAN PROGRAMMER TWICE AND NOTHING WAS FOUND. IT WAS NOTED THAT X-RAYS WERE ALSO FINE. IT WAS NOTED THAT THE PATIENT BELIEVED THAT THERE MAY BE A LOOSE WIRE OR CRACKED SILICONE. IT WAS REPORTED THE PATIENT RECHARGED EVERY DAY OR EVERY OTHER DAY FOR ABOUT 4 HOURS, WHICH WAS NORMAL FOR THE PATIENT. IT WAS ALSO REPORTED THE PATIENT STATED THAT ¿MORE WIRES WOULD BE ATTACHED¿ FOR BETTER PAIN COVERAGE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH A HEALTH CARE PROVIDER TO DISCUSS MORE ABOUT ATTACHING THE WIRES. IT WAS NOTED THAT THE PATIENT WAS NOT ABLE TO HAVE AN MRI ¿BECAUSE OF ALL THE OTHER METAL IN HIS BODY.¿ IT WAS NOTED THAT THE PATIENT WAS WAITING FOR APPROVAL OF A CT SCAN TO SEE IF THAT SHOWED ANYTHING WITH THE IMPLANTS. IT WAS NOTED THAT WHEN THE ¿ADDITIONAL WIRE ARE ATTACHED¿ THE HEALTH CARE PROVIDER WOULD CHECK OTHER ASPECTS OF THE SYSTEM. IT WAS NOTED THAT THE PATIENT HAD THE INS OFF FOR 1.5 MONTHS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290881 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1