BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA VALVE, REGULAR, PERFORMANCE LEVEL 1

    MDR report key: 222248 · Received May 5, 1999

    Report

    Report Number
    222248
    Event Type
    Injury
    Date Received
    May 5, 1999
    Date of Event
    March 31, 1999
    Report Date
    April 2, 1999
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 3/26/1999 PT HAD SHUNT REPLACED THAT HAD INITIALLY BEEN PLACED 4/1998 (MFR. REPORT #2021898-1999-00058, - 00059). THE PT CONTINUED TO BE CONFUSED AND ALSO HAD SPEECH DIFFICULTIES. THE SHUNT WAS PATENT AND SEEMED TO BE FUNCTIONING. SHUNT WAS REPLACED ON 3/31/1999. REFERENCE REPORT #2021898-1999-00061 FOR PERITONEAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA VALVE, REGULAR, PERFORMANCE LEVEL 1 Implant CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC PS MEDICAL NA R6016

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention