BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3140309 · Received May 31, 2013

    Report

    Report Number
    3007566237-2013-01810
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 18, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID NEU_RECHARGER_ACC, PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD MOVED FROM (B)(6) AND FELL ON THE AREA OF HIS IMPLANT LAST WEEK ON SOME ICE AT THE END OF HIS DRIVEWAY. IT WAS NOTED THAT THE PATIENT INJURED HIS SHOULDER IN THE FALL. AT THAT TIME THE PATIENT NOTICED HE HAD LOST HIS PATIENT PROGRAMMER AND HIS RECHARGER WOULD NOT POWER ON THE DEVICE. IT WAS NOTED THAT THE PATIENT HAD NOT HAD HIS INS CHECKED IN APPROXIMATELY 9 MONTHS SO HE WAS NOT SURE OF THE BATTERY LIFE, BUT HE WAS IN PAIN AND WAS THINKING IT COULD BE FROM THE CLIMATE CHANGE FROM HIS RECENT MOVE AS WELL AS THE FALL A WEEK AGO. IT WAS ALSO REPORTED THAT RECENTLY IT WAS TAKING LONGER WHEN THE PATIENT RECHARGED HIS INS AND THE BATTERY WOULD NOT CHARGE COMPLETELY. THE PATIENT THOUGHT HIS RECHARGER WAS FUNCTIONING FINE AND IT WAS THE INS THAT WAS CAUSING THE ISSUE. IT WAS LATER REPORTED THAT A REPLACEMENT PROGRAMMER WAS ORDERED FOR THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD BEEN WITHOUT THE PROGRAMMER FOR ABOUT 4-5 MONTHS. WHEN THE PATIENT RECHARGED HE COULD ONLY CHARGE FOR ABOUT TWO HOURS BECAUSE IT STARTED TO BURN THE SKIN. IT WAS REPORTED THAT THIS ALL STARTED AFTER THE FALL IN (B)(6), WHERE THE PATIENT FELL ON HIS SHOULDER, HIP AND FOOT. AFTER THE FALL IT BURNED LIKE CRAZY, BUT THE BURNING FINALLY WENT AWAY. IT WAS REPORTED THAT AFTER THE FALL THE PATIENT HAD SURGERY AND WAS WAITING TO GET THE PAIN IN HIS FEET FIXED BY USING THE PROGRAMMER. IT WAS NOTED THAT THE PATIENT HAD CANCER AND THE RADIATION DID A LOT OF DAMAGE, AND SINCE THEN HE HAD PROBLEMS WITH HIS LEGS AND WAS NOT SURE WHETHER THIS WAS PART OF THE SYMPTOMS AS WELL. IT WAS REPORTED THAT THE PATIENT USUALLY HAD 8 BOXES AND CHARGED DIRECTLY ON THE SKIN, AND BEFORE THE FALL IT TOOK HIM AN HOUR, NOW AFTER 3 HOURS IT STARTED TO BURN. THE PATIENT STATED THAT THE TOP RIGHT CORNER FELT LIKE A NAIL STICKING HIM AND HE WOULD HAVE TO STOP THE SESSION AND WAIT AWHILE TO GET IT GOING AGAIN. IT WAS REPORTED THAT THE PATIENT HAD NOT HAD A STIMULATION SENSATION SINCE (B)(6) BECAUSE OF NOT HAVING THE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT WAS UNABLE TO TURN THEIR STIMULATION ON. IT WAS NOTED THAT THEIR DEVICE STARTS GETTING HOT AND BURNING THEM WHEN THEY RECHARGE. IT WAS NOTED THAT THE PATIENT COULDN'T GET THEIR DEVICE TO TURN OFF.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE THERAPY NEVER REALLY WORKED FOR HIM SINCE IMPLANT ON (B)(6) 2007. THE PATIENT WAITED FOR IT TO WORK, BUT IT NEVER DID UNLESS HE WAS LYING DOWN. THE PATIENT REPORTED FEELING STIMULATION WHERE HE DIDN¿T NEED IT SINCE IMPLANT AND THAT THE PAIN IN HIS FEET GRADUALLY STARTED IN 2009. THE PATIENT REPORTED THAT HE WANTED THE THERAPY DEVICE REMOVED. HE WANTED TO CONSULT WITH A SURGEON TO HAVE IT REMOVED, HOWEVER HE DID NOT HAVE A PRIMARY HEALTH CARE PROVIDER THAT MANAGED THE DEVICE, AND HE REQUESTED HEALTH CARE PROVIDER LISTINGS FOR ONE NEAR HIS AREA. THERE WAS NO PLANNED SURGICAL INTERVENTION AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THE DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. IT WAS NOTED THAT THE PATIENT WAS NEW TO THIS AREA AND HAD OTHER PAIN PROBLEMS FROM A FALL IN (B)(6) 2012. IT WAS NOTED THAT IT WAS A VERY TRYING TIME FOR THE PATIENT AND THE BEST THING FOR THE PATIENT WAS TO RECEIVE THEIR NEW REMOTE TO VERIFY IF THEY HAD DAMAGED THE UNIT THAT WAS IMPLANTED ON (B)(6) 2007, WHEN THEY FELL FROM THE ICE ON ROAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241737 UNKNOWN NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR