BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-VENTRICULAR CATHETER STANDARD 23 CM

    MDR report key: 40491 · Received September 25, 1996

    Report

    Report Number
    40491
    Event Type
    Injury
    Date Received
    September 25, 1996
    Date of Event
    August 15, 1996
    Report Date
    August 26, 1996
    Manufacturer
    MEDTRONICS PS MEDICAL
    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

    PT TAKEN TO SURGERY 8/13/96 FOR REVISION OF V-P SHUNT. TAKEN BACK TO SURGERY 8/15/96 FOR REVISION OF V-P SHUNT DUE TO ALLEGED INSUFFICIENT FUNCTIONING OF CO'S VENTRICULAR CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-VENTRICULAR CATHETER STANDARD 23 CM Implant CNS FLUID SHUNTS AND COMPONENTS JXG MEDTRONICS PS MEDICAL * J3362

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention