BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4251170 · Received November 14, 2014

    Report

    Report Number
    3007566237-2014-03337
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HEALTHCARE PROVIDER (HCP) WAS NO MORE AN HCP AND THE PATIENT HAD BEEN IN SUICIDE PAIN FOR THE LAST 2 MONTHS PRIOR. AT THE TIME OF THE REPORT THE PATIENT DIDN¿T KNOW HOW TO GET RID OF IT WHEN THEY GOT SOMETHING SOON. INFORMATION REGARDING IF THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738718 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other