BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3172729 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10441
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    December 1, 2012
    Report Date
    May 23, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ¿LOOKING FOR SOMETHING FOR BRAIN DEADNESS.¿ THE PATIENT REPORTED ¿HIS BRAIN WAS GONE." IT WAS UNCLEAR WHAT THIS MEANT. CANCER WAS FOUND IN THE PATIENT¿S HEAD TWELVE YEARS AGO, AND FOLLOWING RADIATION TREATMENT THE PATIENT STARTED HAVING REAL BAD PAIN ON THE LEFT HAND SIDE OF HIS FACE. IT WAS REPORTED THAT THE RADIATION MACHINE HAD ¿EATEN¿ THE JAW BONE OUT ABOVE FOUR TEETH. ON (B)(6) 2012 THE PATIENT HAD A DEVICE IMPLANTED IN THE LEFT HAND SIDE OF HIS HEAD. THE WIRE RAN FROM THE JAW AROUND THE EYE, DOWN THE LEFT NECK, OVER THE LEFT EAR, AND DOWN TO THE CHEST WHERE THE STIMULATION AND BATTERY WERE. THE SHARP PAIN WAS NOW GONE, BUT THE PATIENT WAS HAVING AN UNUSUAL FEELING UNDER HIS LEFT EYE AND LEFT NASAL. THE FEELING DIDN¿T HURT BUT WAS DESCRIBED AS UNCOMFORTABLE, AND THE PATIENT WAS HAVING DRAINAGE FROM HIS LEFT EYE AND LEFT NASAL. ON (B)(6) 2013 THE PATIENT WENT TO THE HCP WHO DETERMINED THE WIRES WERE COMING THROUGH HIS LEFT NASAL. IT WAS NOTED THAT THE PATIENT WAS INTERESTED IN KEEPING THE DEVICE IMPLANTED BECAUSE IT WAS A PLEASURE NOT TO HAVE THE PAIN THAT HE HAD PRIOR TO HAVING IT INSTALLED. IT WAS REPORTED THAT THE PATIENT WAS HAVING A FUZZY FEELING ON THE LEFT SIDE AND HAD GONE TO THE ER IN APRIL BECAUSE OF THE UNCOMFORTABLE FEELING IN HIS FACE. HE WAS GIVEN TWO ANTIBIOTICS THAT HELPED WITH THE DRAINAGE, WHICH THE PATIENT HAD NOTICED FOR THE PAST 4-5 MONTHS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273682 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 00064 YR Required Intervention