BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER HEYER-SCHULTZE

    MDR report key: 16748 · Received August 28, 1994

    Report

    Report Number
    16748
    Event Type
    Injury
    Date Received
    August 28, 1994
    Date of Event
    November 23, 1993
    Report Date
    February 10, 1994
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    LID
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SHUNT PLACEMENT WAS FOR NORMAL PRESSURE HYDROCEPHALUS, WITH GOOD RESPONSE: GAIT & LETHARGY IMPROVED. HOWEVER, OVER A 2 WEEK PERIOD PRIOR TO REMOVAL, PT. BECAME INCREASINGLY LETHARGIC & CONFUSED. TEMP. 104 AND MENTAL STATUS SOMNOLENT ON ADMISSION. INFECTION DID NOT RESPOND TO 10 DAYS OF IV ANTIBIOTICS. SHUNT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER HEYER-SCHULTZE Implant V-P SHUNT LID BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other