BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX DIAMOND II VALVE KIT

    MDR report key: 330050 · Received March 28, 2001

    Report

    Report Number
    2518608-2001-00003
    Event Type
    Other
    Date Received
    March 28, 2001
    Date of Event
    February 3, 2001
    Report Date
    March 19, 2001
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "A VALVE WAS PLACED AND THERE WAS NO PROBLEM DURING INSERTION AND THE SHUNT FLOWED NORMALLY, THE CSF WAS CLEAR. THE NEXT MONTH AFTER PLACEMENT, THE PATIENT SHOWED SYMPTOMS OF SHUNT BLOCKAGE, THIS WAS INVESTIGATED BY THE PHYSICIAN. HE EXPOSED THE TIP OF THE PERITONEAL CATHETER. CSF WAS FLOWING SLOWLY (ABOUT 1 DROP EVERY 15 SECONDS), ALSO THE CSF WAS STRAINED WITH BLOOD. HE THEN REMOVED THE VALVE AND EXPOSED THE END OF THE VENTRICULAR CATHETER. CSF WAS CLEAR AND FLOWING NORMALLY. THE PATIENT WAS PUT ON AN EXTERNAL DRAIN AND A SAMPLE OF THE CFS WAS TAKEN FOR ANALYSIS. NO INFECTION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14245 PHOENIX DIAMOND II VALVE KIT HYDROCEPHALUS SHUNT JXG PHOENIX BIOMEDICAL CORP. NA C21

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other