BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2895381 · Received January 3, 2013

    Report

    Report Number
    3007566237-2013-00026
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DEVICE SYSTEM WAS BEING EXPLANTED. TWO DAYS LATER, IT WAS REPORTED THAT THE SYSTEM HAD BEEN PUT IN FOR PERIPHERAL NERVE STIMULATION IN THE BRACHIAL PLEXUS AREA. THE REPORTER STATED THAT THE PATIENT HAD NEVER HAD GOOD RELIEF, THE LEAD HAD "BEEN IN FOREVER" AND WAS NOW "PRETTY SCARRED IN," AND THE DOCTOR WOULD JUST TAKE THE IMPLANTABLE NEUROSTIMULATOR OUT BECAUSE IT HAD BEEN BOTHERING THE PATIENT. THE EXPLANT WAS SCHEDULED FOR (B)(6) 2012. THE REPORTER STATED THAT THE SYSTEM "NEVER WORKED" AND THE DEVICE HAD BEEN DEAD FOR YEARS. IT WAS NOTED THAT THE PATIENT WAS GETTING ADEQUATE COVERAGE USING ANOTHER DEVICE. TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT HADN'T USED THE DEVICE IN YEARS AND THE DEVICE HAD REACHED THE "END OF LIFE" A WHILE AGO. THE DEVICE HAD BEEN EXPLANTED. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3456 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention