BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA VALVE, SMALL, PERFORMANCE LEVEL 1

    MDR report key: 63678 · Received January 15, 1997

    Report

    Report Number
    2021898-1997-00005
    Event Type
    Injury
    Date Received
    January 15, 1997
    Date of Event
    October 18, 1996
    Report Date
    December 18, 1996
    Manufacturer
    MEDTRONICS PS MEDICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATHED BY THE CO FOR PATENCY, PRESSURE/FLOW CHARACTERISTICS, PREIMPLANTATION PRESSURE, LEAKAGE AND DIPHONING. ALSO RETURNED WITH THE VALVE WAS ANOTHER MFR'S CYLINDRICAL ANTI-CHAMBER CONTAINING A METAL GUARD. THIS PRODUCT WAS NOT TESTED. THE VALVE MET ALL THE CO'S PERFORMANCE SPECIFICATIONS. THIS INCIDENT WAS REPORTED TWICE-FIRST ON 11/20/96 AND SECOND ON 12/18/96. IT WAS CONFIRMED BY THE DISTRIBUTOR ON 2/7/97 THAT BOTH REPORTS REFERRED TO ONLY ONE INCIDENT. MEDWATCH REPORT NUMBER 2021898-1996-92 ALSO FILLED,.

    Description of Event or Problem · 1

    ADDITION TO INITIAL EVENT DESCRIPTION: CEREBROSPINAL FLUID LEAKAGE (CODE 1772) WAS REPORTED ON MEDWATCH REPORT RECEIVED BY HOSPITAL WHEN INCIDENT WAS FIRST REPORTED (MANUFACTURER REPORT NUMBER 2021898-1996-92). SEE H10 FOR MORE DETAILS ON THE TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA VALVE, SMALL, PERFORMANCE LEVEL 1 Implant CNS FLUID SHUNTS AND COMPONENTS JXG MEDTRONICS PS MEDICAL NA E2093

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention