BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3102423 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01528
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS HAD 7 SURGERIES. IT WAS STATED THAT THE SURGERIES HAD "TAKEN AWAY EVERYTHING" FROM THE PATIENT. IT WAS NOTED THAT "THE UNIT" WAS NOT DOING ALL THE IT SHOULD. IT WAS STATED THAT THE PATIENT HAD A DIFFERENT DEVICE IMPLANTED TOO, AND IT WAS UNCLEAR IF THE ALL OF THE SURGERIES WERE RELATED TO THAT, OR THE STIMULATOR, OR SOMETHING ELSE ENTIRELY. IT WAS NOT CLEAR WHAT "TAKEN AWAY EVERYTHING" MEANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203223 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention