BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA ON-OFF FLUSHING RESERVOIR

    MDR report key: 7490013 · Received May 7, 2018

    Report

    Report Number
    7490013
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    March 14, 2018
    Report Date
    May 2, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT RETURNED TO SURGERY WITHIN 24 HOURS BECAUSE THE SHUNT VALVE THAT WAS IMPLANTED YESTERDAY WAS DEFECTIVE. A NEW VALVE WAS PLACED TODAY. PRE-PROCEDURE DIAGNOSIS: INTEGRA ON-OFF VALVE FAILURE. POST-PROCEDURE DIAGNOSIS: SAME AS PRE-PROCEDURE DIAGNOSIS. PROCEDURE NAME: ELECTIVE. ESTIMATED BLOOD LOSS: MINIMAL. PROCEDURE DESCRIPTION: REPLACEMENT OF INTEGRA VALVE. PROCEDURE FINDINGS: MALFUNCTIONING INTEGRA VALVE, STUCK IN OFF POSITION. WOUND CLASSIFICATION: CLEAN-CONTAMINATED. SPECIMENS: NONE. THE PRODUCT IS AN ON/OFF VALVE MFG INTEGRA MODEL # NL8500150 LOT # 1162715.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333725 INTEGRA ON-OFF FLUSHING RESERVOIR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG INTEGRA LIFESCIENCES CORPORATION NL8500150 1162715

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR