BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA VALVE, REGULAR, PERFORMANCE LEVEL 1.5

    MDR report key: 46563 · Received October 28, 1996

    Report

    Report Number
    2021898-1996-00077
    Event Type
    Injury
    Date Received
    October 28, 1996
    Report Date
    September 30, 1996
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INDICATED THAT THE PRODUCT WAS RETURNED. HOWEVER, THE PRODUCT THAT WAS RETURNED WAS ANOTHER VALVE, NOT THIS VALVE. PLEASE REFER TO REPORT NUMBER 2021898-1996-00075.

    Description of Event or Problem · 1

    PT SUFFERED FROM UNDERDRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA VALVE, REGULAR, PERFORMANCE LEVEL 1.5 Implant CNS FLUID SHUNT AND COMPONENT JXG MEDTRONIC PS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention