BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA SHUNT ASSEMBLY, REGULAR, PERFORMANCE LEVEL 1

    MDR report key: 168331 · Received May 18, 1998

    Report

    Report Number
    2021898-1998-00037
    Event Type
    Injury
    Date Received
    May 18, 1998
    Date of Event
    March 18, 1998
    Report Date
    April 14, 1998
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SHUNT WAS IMPLANTED ON 4/20/1995 AND REPLACED ON 3/18/1998 DUE TO OCCLUSION. IT WAS REPLACED WITH A LEVEL 0.5 DELTA VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT ASSEMBLY, REGULAR, PERFORMANCE LEVEL 1 Implant CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC PS MEDICAL NA H2283

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention