BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STIMULATORS

    MDR report key: 17534467 · Received August 12, 2023

    Report

    Report Number
    MW5141368
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    February 24, 2016
    Manufacturer
    UNKNOWN
    Product Code
    PMP
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE (BREEL, J., ZUIDEMA, X., SCHAPENDONK, J., LO, B., WILLE, F.F. TREATMENT OF CHRONIC POST-SURGICAL PAIN WITH DORSAL ROOT GANGLION (DRG) STIMULATION (10701). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 65.) THAT 7 PATIENTS WITH DORSAL ROOT GANGLION (DRG) STIMULATION FOR CHRONIC POST? SURGICAL NEUROPATHIC PAIN DID NOT REPORT GREATER THAN 50% PAIN RELIEF AFTER SIX MONTHS OF TREATMENT. LESS THAN 3 PATIENTS WITH DRG STIMULATION FOR CHRONIC POST-SURGICAL NEUROPATHIC PAIN DID NOT REPORT PAIN RELIEF IN THE AREAS OF THEIR NORMAL PAIN AFTER SIX MONTHS OF TREATMENT. LESS THAN 8 PATIENTS WITH DRG STIMULATION FOR CHRONIC POST-SURGICAL NEUROPATHIC PAIN DID NOT REPORT PARESTHESIAS IN THEIR AREA OF NORMAL PAIN WHILE USING THEIR 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
    1085872 UNKNOWN STIMULATORS DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF PMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown