BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SEPS KIT

    MDR report key: 5766747 · Received July 1, 2016

    Report

    Report Number
    2021898-2016-00228
    Event Type
    Injury
    Date Received
    July 1, 2016
    Report Date
    June 3, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    ERL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL DEVICE INFORMATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. LITERATURE ARTICLE: TRANEXAMIC ACID FOR TREATMENT OF RESIDUAL SUBDURAL HEMATOMA AFTER BEDSIDE TWIST-DRILL OMAR TANWEER, FABIO A FRISOLI, CRYSTAL BRAVATE, GILLIAN HARRISON, DONATO PACIONE, DOUGLAS KONDZIOLKA, PAUL P. HUANG WORLD NEUROSURGERY 2016 91:29-33.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED BY MEDTRONIC NEUROSURGERY UPON REVIEW OF SCIENTIFIC LITERATURE: IN OUR PILOT STUDY, CHRONIC SDH VOLUMES WERE REDUCED BY 40.74% AFTER SEPS DRAINAGE. THE RESIDUAL VOLUME WAS REDUCED BY AN ADDITIONAL 91.31% DURING ORAL TXA TREATMENT. NO PATIENTS DEVELOPED DELAYED RECURRENCE OR EXPANSION OF THEIR SDHS. ALL PATIENTS WERE SYMPTOMATIC ON PRESENTATION. THE MOST COMMON SYMPTOMS WERE ALTERED MENTAL STATUS, HEADACHE, AND GAIT DISTURBANCE. ONE PATIENT REQUIRED A CRANIOTOMY AS A RESULT OF EXPANSION OF SUBDURAL HEMATOMA AFTER SUBDURAL EVACUATION USING SEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419021 UNKNOWN SEPS KIT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R