BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTA SHUNT KIT REGULAR, PL 1.5

    MDR report key: 1843962 · Received September 21, 2010

    Report

    Report Number
    2021898-2010-00227
    Event Type
    Death
    Date Received
    September 21, 2010
    Date of Event
    August 22, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHUNT WAS IMPLANTED ON (B)(6), 2010, AND THE PT WAS KEPT AT REST IN BED AT THE HOSPITAL. ON (B)(6), 2010, THE PT FAINTED SUDDENLY AFTER GOING TO THE TOILET. THE CT INDICATED THAT THE CEREBRAL VENTRICLES WERE COLLAPSED. THE DOCTOR CONSIDERED THAT THE DELTA CHAMBER MAY BE DISABLED. ON (B)(6), 2010 THE PT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT REGULAR, PL 1.5 JXG MEDTRONIC NEUROSURGERY NA C65025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death