BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR, UNKNOWN

    MDR report key: 3082051 · Received April 29, 2013

    Report

    Report Number
    3007566237-2013-01452
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 12, 2013
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS "SEVERELY MAIMED" FROM THE NEUROSTIMULATOR TRIAL AND HAD "SOME INSANE THINGS GOING ON" AND NUMBNESS "ALL OVER HIS BODY" AS THE RESULT THAT HE HAD NEVER HAD BEFORE. IT WAS STATED THAT THE PATIENT COULD"GO ON AND ON" WITH ALL OF THE ADVERSE EFFECTS. IT WAS STATED THAT DURING THE SURGERY FOR THE TRIAL THE DOCTOR ATTEMPTED TO PUT THE NEUROSTIMULATOR IN PATIENT'S BODY AND THE PATIENT KEPT YELLING AND SCREAMING THAT SOMETHING WAS TERRIBLY WRONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185717 EXTERNAL NEUROSTIMULATOR, UNKNOWN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other