BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6537258 · Received May 2, 2017

    Report

    Report Number
    3007566237-2017-01676
    Event Type
    Injury
    Date Received
    May 2, 2017
    Report Date
    May 2, 2017
    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

    CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM A CONSUMER REPORTED THAT "6 MO A PATIENT WAS TOLD PHANTOM PAIN" WHEN MEANWHILE THEY "WENT IN" AND IT WAS "FRIED LEADS (WIRES) NOT PHANTOM PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319658 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention