BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRIX NL950-V

    MDR report key: 270081 · Received March 17, 2000

    Report

    Report Number
    2023988-2000-00001
    Event Type
    Death
    Date Received
    March 17, 2000
    Date of Event
    December 26, 1999
    Report Date
    March 17, 2000
    Manufacturer
    INTEGRA NEUROCARE L.L.C.
    Product Code
    HCA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 02/16/2000, AN INTEGRA NEUROCARE ("INC") EMPLOYEE RECEIVED INFO ALLEGING THAT AN INTRACRANIAL PRESSURE MONITORING CATHETER, INC MODEL #NL950-V, WAS USED TO MONITOR A PT WHO WAS POST CRANIOTOMY DUE TO A DEPRESSED SKULL FRACTURE AND SUBDURAL HEMATOMA. ACCORDING TO THE RPTR, "THE MONITOR [WAS] PLACED A TOTAL OF 4 DAYS. OVER AT LEAST THE FINAL TWO DAYS THE FIBER OPTIC DETECTED INTRACRANIAL PRESSURE WAS NEGATIVE (-15 TO -20). THE PT'S [CONDITION] SLOWLY DETERIORATED THE FINAL TWO DAYS BUT, UNFORTUNATELY, THE NURSE FAILED TO RECOGNIZE THESE SIGNS AND TRUSTED THE LOW TO NEGATIVE NUMBER." THE RPTR EXPRESSED THE BELIEF THAT "THE NURSE WOULD HAVE REACTED DIFFERENTLY IF THERE WAS AN ACCURATE REPORT OF INTRACRANIAL PRESSURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRIX NL950-V INTRACRANIAL PRESSURE MONITORING KIT HCA INTEGRA NEUROCARE L.L.C. NL950-V UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death