BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRIGEMINAL GANGLION STIMULATORS AND LEADS

    MDR report key: 17536395 · Received August 12, 2023

    Report

    Report Number
    MW5143283
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    March 28, 2016
    Manufacturer
    ST. JUDE
    Product Code
    GZF
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE (WILLIAM, A., AZAD, T.D., BRECHER, E., CHERRY, T., BERNSTEIN, I., BRUCE, D.M., ROHRER, S., SMITH, Z., WILLIAM, M., SABELMAN, E., HEIT, G., PEZESHKIAN, P.,SEDRAK, M. TRIGEMINAL AND SPHENOPALATINE GANGLION STIMULATION FOR INTRACTABLE CRANIOFACIAL PAIN-CASE SERIES AND LITERATURE REVIEW. ACTA NEUROCHIRURGICA. 2016. 158:513-520. DOI: 10.1007 /S00701-015-2695-Y) THAT THREE PATIENTS WHO HAD TRIGEMINAL GANGLION TRIAL IMPLANTS WITH PERCUTANEOUS (HARTEL-TYPE APPROACH) TRG STIMULATION HAD UNTOWARD MASSETER CONTRACTION, LIMITING STIMULATION EFFECTS, REGARDLESS OF ELECTRODE TIP LOCATION BEYOND THE CLIVUS. FOR THIS REASON, ELECTRODE GRIDS WERE PLACED VIA CRANIOTOMY OVER MECKEL'S CAVE, WHICH ALLOWED SELECTIVE STIMULATION OF THE TRIGEMINAL NERVE SUBDIVISIONS WITHOUT THIS SIDE EFFECT. (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
    1354623 UNKNOWN TRIGEMINAL GANGLION STIMULATORS AND LEADS STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) GZF ST. JUDE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown