BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED SPINAL CORD STIMULATOR

    MDR report key: 17534297 · Received August 12, 2023

    Report

    Report Number
    MW5141200
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    January 6, 2015
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED IN A LITERATURE ARTICLE THAT THE PATIENT EXPERIENCED SEVERE SIDE EFFECTS. (THAKKAR N, CONNELLY NR, VIEIRA P. GASTROINTESTINAL SYMPTOMS SECONDARY TO IMPLANTED SPINAL CORD STIMULATORS. ANESTH ANALG 2003; 97: 547-9. DOI: 10.1213/01.ANE.0000068981.30265.82). (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
    783877 IMPLANTED SPINAL CORD STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ADVANCED NEUROMODULATION SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown