BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3070357 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01370
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN TOLD THE DEVICE WOULD LAST 16 YEARS, BUT HAD HAD SEVERAL DEVICES THAT LASTED NO LONGER THAN THREE YEARS. THE PATIENT STATED THAT IT WAS MOSTLY BECAUSE OF HER USAGE AND LEVELS. IT WAS REPORTED THAT THE PATIENT WAS TOLD THAT SHE HAD HIGH LEVELS AND NEVER TURNED THE SYSTEM OFF. IT WAS NOTED THAT THE PATIENT NEVER TURNED THE SYSTEM OFF BECAUSE IF SHE DID SHE COULDN'T WALK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAS HAD 7 STIMULATORS: THE CURRENT ONE HAS LASTED LONGER ANY OF THE ONES SHE'S HAD. IT WAS NOTED THAT MOST OF THEM DIED WITHIN 3 YEARS. IT WAS REPORTED THAT SHE USED HIGH LEVELS (OF STIMULATION) AND IT WAS ON 24 HOURS A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170984 UNKNOWN NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention