BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SEPS KIT

    MDR report key: 3095923 · Received May 3, 2013

    Report

    Report Number
    2021898-2013-00171
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    June 10, 2012
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. LITERATURE ARTICLE: "SUBDURAL EVACUATING PORT SYSTEM (SEPS) - MINIMALLY INVASIVE APPROACH TO THE MANAGEMENT OF CHRONIC/SUBACUTE SUBDURAL HEMATOMAS," AMIT, SINGLAA, WALTER P. JACOBSENB, IGOR R. YOSUPOVC, DAVID A. CARTERA, PUBLISHED IN CLINICAL NEUROLOGY AND NEUROSURGERY 112 (2013) 425-431.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED THE RESULTS OF A RETROSPECTIVE STUDY OF 52 CONSECUTIVE ADULT PTS WITH CHRONIC/SUBACUTE SUBDURAL HEMATOMAS (SDH) TREATED WITH THIS PRODUCT OVER A 3 YEAR PERIOD AT A SINGLE FACILITY. THE ARTICLE STATES THAT 38 OF THE 52 PTS SHOWED CLINICAL IMPROVEMENT FOLLOWING SDH DRAINAGE WITH THE PRODUCT, 10 OF THE 52 PTS DID NOT SHOW CLINICAL IMPROVEMENT FOLLOWING SDH DRAINAGE WITH THE DEVICE, AND THAT 4 OF THE 52 PTS BECAME CLINICALLY WORSE FOLLOWING DRAINAGE WITH THE PRODUCT. ACCORDING TO THE ARTICLE, 18 OF THE 52 PTS REQUIRED AN ADDITIONAL OPERATION FOR TREATMENT OF THEIR SDH WITHIN 6 MONTHS OF THEIR INITIAL OPERATION. THE ARTICLE STATES THAT FOR 14 OF THE 18 PTS THAT REQUIRED A SECOND PROCEDURE, THERE WAS A SIGNIFICANT CONTINUATION OF THE PTS' SYMPTOMS FOLLOWING THE INITIAL PROCEDURE, WHICH WAS THOUGHT NOT TO HAVE ADEQUATELY DRAINED THE SDH. ACCORDING TO THE ARTICLE, 4 OF THE 18 PTS EXPERIENCED RELIEF OF THEIR SYMPTOMS FOLLOWING THE INITIAL PROCEDURE, BUT BECAME AFFLICTED WITH A RECURRENCE OF AN IPSILATERAL SDH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194033 UNK SEPS KIT JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization