BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUOHY 14-GAUGE NEEDLE

    MDR report key: 14161840 · Received April 20, 2022

    Report

    Report Number
    2021898-2022-00098
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    July 16, 2021
    Report Date
    April 20, 2022
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DOTAN, G., COHEN, N.H., QURESHI, H.M., ROOTMAN, M.S., NEVO, Y., KERSHENOVICH, A. EXTERNAL LUMBAR DRAINAGE IN PROGRESSIVE PEDIATRIC I DIOPATHIC INTRACRANIAL HYPERTENSION. J NEUROSURG PEDIATR. 2021. (28) 490¿496. DOI: 10.3171/2021.2.PEDS2143. OBJECTIVE PEDIATRIC IDIOPATHIC INTRACRANIAL HYPERTENSION (IIH) IS CHARACTERIZED BY INCREASED INTRACRANIAL PRESSURE DESPITE NORMAL CE REBROSPINAL FLUID AND NEUROIMAGING FINDINGS. INITIAL MANAGEMENT IS TYPICALLY MEDICAL; HOWEVER, NEARLY 10% OF CHILDREN WILL EVENTUALLY REQUIRE SURGERY FOR PERSISTENT HEADACHE AND/OR VISION LOSS. EXTERNAL LUMBAR DRAINAGE, WHICH IS A CONSIDERABLY SAFER TREATMENT OPTI ON, HAS NOT BEEN ADEQUATELY ANALYZED IN CHILDREN WITH MEDICALLY REFRACTORY IIH. METHODS THE AUTHORS CONDUCTED A SINGLE-INSTITUTION RETROSPECTIVE ANALYSIS OF CHILDREN WITH MEDICALLY REFRACTORY IIH WHO HAD UNDERGONE EXTERNAL LUMBAR DRAIN (ELD) PLACEMENT BECAUSE OF WORSENING PAPILLEDEMA, REFLECTED AS INCREASED RETINAL NERVE FIBER LAYER (RNFL) THICKNESS ON OPTICAL COHERENCE TOMOGRAPHY (OCT) TESTING. THE MAIN OUTCOME MEASURES WERE EFFECTS OF EXTERNAL LUMBAR DRAINAGE ON PAPILLEDEMA RESOLUTION, SYMPTOMS, AND VISION. RESULTS THE AUTHORS ANALYZED THE MEDICAL RECORDS OF 13 CHILDREN WITH IIH (11 GIRLS, MEAN AGE 15.0 ± 2.3 YEARS) WHOSE MEAN CSF OPENING PRESSURE WAS 45.5 ± 6.8 CM H2O. IN ALL CHILDREN, THE AVERAGE GLOBAL RNFL THICKNESS IN BOTH EYES SIGNIFICANTLY INCREASED AT ELD PLACEMENT (RIGHT EYE 371.8 ± 150.2 ¿M, LEFT EYE 400.3 ± 96.9 ¿M) COMPARED WITH PRESENTATION THICKNESS (RIGHT EYE 301.6 ± 110.40 ¿M, LEFT EYE 350.2 ± 107.7 ¿M) DESPITE ACETAZOLAMIDE MEDICAL THERAPY (20¿30 MG/KG/DAY), LEADING TO ELD PLACEMENT AFTER 9.5 ± 6.9 DAYS (RANGE 3¿29 DAYS). AFTER ELD INSERTION, THERE WAS HEADACHE RESOLUTION, GRADUAL AND CONTINUOUS IMPROVEMENT IN OPTIC DISC THICKNESS, AND PRESERVATION OF GOOD VISION. CONCLUSIONS ELD PLACEMENT IN CHILDREN WITH MEDICALLY REFRACTORY IIH WHO DEMONSTRATED WORSENING PAPILLEDEMA WITH INCREASED RNFL THICKENING ON OCT TESTING TYPICALLY RESULTS IN SYMPTOM RELIEF AND DISC EDEMA RESOLUTION WITH GOOD VISUAL OUTCOME, OFTEN PREVENTING THE NEED FOR ADDITIONAL DEFINITIVE SURGERIES THAT CARRY GREATER FAILURE AND MORBIDITY RISKS. REPORTED EVENTS: ALL PATIENTS EXPERIENCED WORSENING OPTIC DISC SWELLING THAT LED TO THE INSERTION OF A TEMPORARY ELD REMOVED AS PLANNED AFTER 5 DAYS IN 10 PATIENTS. IN 3 PATIENTS THE ELD WAS REMOVED EARLIER THAN INTENDED, AFTER ONLY 3 DAYS, BECAUSE OF CSF LEAKAGE AROUND THE DRAIN. 3 CHILDREN (23%) EVENTUALLY REQUIRED AN ADDITIONAL SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271496 TUOHY 14-GAUGE NEEDLE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 27186

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Other