BEUDAMED
    FDA Adverse Event Death Summary report: N

    CERTAS PLUS

    MDR report key: 5027388 · Received August 19, 2015

    Report

    Report Number
    MW5055696
    Event Type
    Death
    Date Received
    August 19, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 19, 2015
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE, 2 WEEKS S/P VP SHUNT REPLACEMENT. WAS FOUND TO BE IN CARDIAC ARREST AT HOME, WAS TRANSPORTED TO HOSPITAL WHERE HE WAS FOUND TO HAVE NO NEUROLOGICAL FUNCTION. TAKEN TO OPERATING ROOM EMERGENTLY FOR SHUNT EXTERNALIZATION. DISCONNECTED THE VENTRICULAR CATHETER FROM THE VALVE AND FOUND A VIGOROUS FLOW WITH INCREASED PRESSURE FROM HIS HEAD. TESTED THE DISTAL FLOW AND THE VALVE WAS FOUND TO HAVE NO EVIDENCE OF ANY FLOW THROUGH IT. TESTED THE DISTAL CATHETER BY ITSELF AND IT HAD NORMAL FLOW. PATIENT WAS DECLARED BRAIN DEAD AND CARE WAS WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549242 CERTAS PLUS CERTAS PLUS JXG CODMAN & SHURTLEFF 828804PL

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death