BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA SHUNT ASSEMBLY, SMALL, PERFORMANCE LEVEL 2

    MDR report key: 200472 · Received December 2, 1998

    Report

    Report Number
    2021898-1998-00147
    Event Type
    Injury
    Date Received
    December 2, 1998
    Date of Event
    November 1, 1998
    Report Date
    November 4, 1998
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SHUNT FRACTURE. TUBING SNAPPED JUST BEYOND DISTAL END OF VALVE. LEAKS WHERE PERITONEAL CATHETER VEVELS TOT HE SMALLER DIAMETER. (SHUNT 2021898-1998-00147, VENTRICULAR CATHETER 2021898-1998-00148.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT ASSEMBLY, SMALL, PERFORMANCE LEVEL 2 Implant CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC PS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention