BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX DIAMOND VALVE

    MDR report key: 362417 · Received November 19, 2001

    Report

    Report Number
    2518608-2001-00009
    Event Type
    Other
    Date Received
    November 19, 2001
    Date of Event
    November 2, 2001
    Report Date
    November 19, 2001
    Manufacturer
    PHOENIX BIOMEDICAL CORP
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "ONE # DCV120 DIAMOND VALVE (LOT 3 B35) WHICH DR. IMPLANTED AS A REVISION VALVE IN A PT IN 2000. THE PT DID WELL UNTIL 2001 WHEN DR. HAD TO REPLACE THE VALVE AS IT WAS NO LONGER FUNCTIONING. THE DR FOUND BOTH THE VENTRICULAR CATHETER AND THE PERITONEAL CATHETER WERE CLEAR BUT THE VALVE WAS BLOCKED. CO HAS INCLUDED THE OPERATING ROOM IMPLANT DEVICE LOG FOR THIS PROCEDURE. DR. WOULD LIKE CO TO INSPECT THE VALVE TO SEE IF THERE IS ANY PARTICULAR REASON FOR THE BLOCKAGE AS HE BELIEVES ALMOST ALL REVISIONS ARE A RESULT OF BLOCKAGE IN THE VENTRICULAR OR PERITONEAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52435 PHOENIX DIAMOND VALVE HYDROCEPHALUS SHUNT JXG PHOENIX BIOMEDICAL CORP * B35

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other