BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 17528354 · Received August 12, 2023

    Report

    Report Number
    MW5135285
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    June 13, 2013
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS INC.
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT SHE HAD 2 IMPLANTABLE NEUROSTIMULATORS (INS) FROM ADVANCED NEUROMODULATION SYSTEMS INC. IT WAS NOTED THAT THE PATIENT'S "LEADS HAD SNAPPED" WITH THE INITIAL INS. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764361 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ADVANCED NEUROMODULATION SYSTEMS INC. UNKNOWN IMPLANTABLE NEUROSTIMULATOR X2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown