BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STIMULATOR

    MDR report key: 17527378 · Received August 12, 2023

    Report

    Report Number
    MW5134310
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    December 13, 2016
    Manufacturer
    ST. JUDE
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE (MILLER, S., WATKINS, L., MATHARU, M. LONG-TERM OUTCOMES OF OCCIPITAL NERVE STIMULATION FOR CHRONIC MIGRAINE: A COHORT OF 53 PATIENTS. THE JOURNAL OF HEADACHE AND PAIN. 2016. 17(1):68. DOI 10.1186/S10194-016-0659-0) THAT 47 PATIENTS WITH ONS FOR CHRONIC MIGRAINE SHOWED A SIGNIFICANT REDUCTION IN MEAN ANY-HEADACHE DAYS, MEAN DAILY PAIN DURATION, AND MEAN DAILY PAIN INTENSITY. ALTHOUGH A SIGNIFICANT REDUCTION OF 3.94 POINTS WAS RECORDED IN HIT-6, THE REDUCTION IN MIDAS WAS NOT SIGNIFICANT. AFFECT SCORES, EQ5D AND SF-36 COMPOSITE SCORES FAILED TO SHOW ANY IMPROVEMENT ACROSS THE COHORT, BUT THE EURO-VAS DID SHOW SIGNIFICANT IMPROVEMENT. (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
    596173 UNKNOWN STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ST. JUDE 1092610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown