BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION IN-LINE VALVE

    MDR report key: 433858 · Received December 20, 2002

    Report

    Report Number
    1226348-2002-00258
    Event Type
    Death
    Date Received
    December 20, 2002
    Date of Event
    November 1, 2002
    Report Date
    November 26, 2002
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS DOCTOR NORMALLY USED CODMAN'S HOLTER VALVE 82-1609 BUT USED INLINE PRECISION VALVE 82-5473 WHICH WAS IDENTIFIED AS BEING AN EQUIVALENT VALVE (BOTH MEDIUM PRESSURE). FOLLOWING VALVE IMPLANTATION, THE PATIENT DEVELOPED A SUBDURAL HEMATOMA AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION IN-LINE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG CODMAN & SHURTLEFF, INC./MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death