BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6085898 · Received November 8, 2016

    Report

    Report Number
    3007566237-2016-03949
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    January 1, 2010
    Report Date
    November 8, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS STATED THAT THE CONSUMER WAS JUST REPORTING AN ADVERSE EVENT. IT WAS REPORTED THAT THE CONSUMER HAD A STIMULATOR FROM THE MANUFACTURER FROM 2007 TO 2010 WHEN IT QUIT WORKING. THE PATIENT HAD PRE-EXISTING BACK ISSUES WHERE THEY HAD A PRE-EXISTING BAD SPINE, PRE-EXISTING DEGENERATIVE DISC DISEASE, AND PRE-EXISTING SPINAL STENOSIS. IT WAS REPORTED THAT THESE PRE-EXISTING MEDICAL CONDITIONS WERE THE REASONS FOR IMPLANT. THE PATIENT DID NOT HAVE THE SERIAL NUMBER OR INFORMATION. IT WAS ASKED BUT NOT DETERMINED WHO THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP) FOR THE STIMULATOR HAD BEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737508 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention