BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAMINO

    MDR report key: 45267 · Received October 29, 1996

    Report

    Report Number
    45267
    Event Type
    Injury
    Date Received
    October 29, 1996
    Date of Event
    September 1, 1996
    Report Date
    October 2, 1996
    Manufacturer
    CAMINO NEUROCARE, INC.
    Product Code
    HCA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED ON 8/25/96 WITH A SUBARACHNOID HEMORRHAGE SECONDARY TO A RUPTURED ANEURYSM. ANGIOGRAM ALSO SHOWED AN UNRUPTURED RIGHT MIDDLE COMMUNICATING ARTERY ANEURYSM. PT UNDERWENT A CRANIOTOMY AND CLIPPING OF BOTH ANEURYSMS. ON 8/26/96 VENTRICULOSTOMY WAS PERFORMED. ON 8/27/96, AN EMERGENCY CRANIOTOMY WAS DONE WITH DECOMPRESSION AND RIGHT TEMPORAL LOBECTOMY. ON 9/1/96, CEREBRAL SPINAL FLUID CULTURE WAS POSITIVE FOR NUMEROUS STAPHYLOCOCCUS AUREUS AND MODERATE STAPHYLOCOCCUS EPIDERMIS. PT'S MENINGITIS WAS TREATED WITH CEFTIZOXIME, NAFCILLIN AND RIFAMPIN. ON 9/2/96 LEAKAGE WAS NOTED AT THE VENTRICULOSTOMY CATHETER SITE. ON 9/7/96, A TRACHEOSTOMY AND J-TUBE WERE PLACD. ON 9/8/96, VENTRICULOSTOMY WAS REMOVED. ON 9/11/96, THE CEREBROSPINAL FLUID CULTURE SHOWED NO GROWTH X4 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAMINO Implant VENTRIX-VENTRICULAR DRAINAGE SYSTEM HCA CAMINO NEUROCARE, INC. NL950 VC *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization SEE DESCRIPTION OF EVENT.