BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SCS SYSTEM

    MDR report key: 17529652 · Received August 12, 2023

    Report

    Report Number
    MW5136577
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    February 24, 2016
    Manufacturer
    UNKNOWN
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE (BREEL, J., WILLE, F.F. AMELIORATION OF CENTRAL PAIN IN SPINAL CORD INJURY VIA DORSAL ROOT GANGLION (DRG) STIMULATION (10706). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 67.) THAT A PATIENT WITH CENTRAL PAIN DUE TO SPINAL CORD INJURY HAD PREVIOUSLY TRIED SPINAL CORD STIMULATION (SCS) WITHOUT SUCCESS. THE PATIENT LATER WENT ON TO DORSAL ROOT GANGLION STIMULATION. (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
    2218607 UNKNOWN SCS SYSTEM STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown