BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA SHUNT ASSEMBLY, REGULAR, PERFORMANCE LEVEL 1

    MDR report key: 146694 · Received January 27, 1998

    Report

    Report Number
    2021898-1998-00010
    Event Type
    Injury
    Date Received
    January 27, 1998
    Date of Event
    November 18, 1997
    Report Date
    December 30, 1997
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SHUNT WAS REVISED ON 11/18/1997 DUE TO PERITONEAL CATHETER FRACTURE AT THE NECK OF A 12 Y/O PT WHO HAD IT IMPLANTED FOR LESS THAN A YEAR.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention