BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2842680 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10652
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37092, LOT# 287970001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 355531, LOT# N299094, IMPLANTED: (B)(6) 2011, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 3550-39, LOT# N298737, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW DETERMINED THE SYMPTOMS WERE UNRELATED TO THE DEVICE, AND THERE WAS NO SERIOUS INJURY OR MALFUNCTION RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN FEELING PAIN. THE PATIENT HAD PAIN IN THEIR HEAD AND NECK. PATIENT HAD CT SCAN OF HEAD AND NECK TO CHECK FOR TUMOR THAT MAY BE CANCEROUS. IT WAS NOTED PATIENT WAS UNABLE TO HAVE A CT SCAN WITH TRACERS/DYES BECAUSE THEY ONLY HAD ONE KIDNEY AND CANNOT DO THAT. IT WAS NOTED THE PATIENT HAD THE STIMULATOR IMPLANTED DUE TO CANCER IN THEIR TERATOMA AND THE STIMULATOR COVERED THE NEUROPATHY FROM THEIR HIPS DOWN. THE PATIENT ALSO HAD NEUROPATHY IN THREE OF THEIR FINGERS TO THEIR ELBOW AND WAS NOW EXPERIENCING SEVERE EAR PROBLEMS. THE PATIENT SAW THEIR DOCTOR AND WAS TOLD "IT MAY BE CANCER, OR NONCANCEROUS TUMOR, SCAR TISSUES WHICH CT SCAN WOULD FIND, BUT MRI WOULD BE BETTER, OR IT COULD BE NEUROLOGICAL WHICH NO TESTS CAN FIND." PATIENT HAS PAIN AND TAKES MEDICATION BUT THE PAIN IS GETTING THROUGH THAT. IT WAS REPORTED THE THERAPY COVERED THE PATIENT'S WHOLE LOWER BODY IN WHICH THE DEVICE WAS IMPLANTED TO COVER. PATIENT HAS HAD SPINAL BLOCKS FOR A BULGING DISC AT C5-6. IT WAS ALSO NOTED THE PATIENT BELIEVES THEY HAD GOLFERS OR TENNIS ELBOW. THE PAIN WAS AT THE INSIDE OF THE ELBOW STRAIGHT DOWN TO THEIR PINKY AND THE NEXT TWO FINGERS ON BOTH ARMS, AND ALSO ON BOTH LEGS. PATIENT HAD SURGERY LAST YEAR IN WHICH "THE PATIENT LOST THEIR LEFT KIDNEY, PARALYZED THEIR LEFT DIAPHRAGM, LUNG, AND THE VENA CAVA WAS NICKED, STROKE, SWOLLEN BRAIN AND EARLY ONSET DEMENTIA FROM THE SURGERY." NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Disability