BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRO VENTRICULAR BOLT ICP MONITORING KIT

    MDR report key: 2162121 · Received July 12, 2011

    Report

    Report Number
    2023988-2011-00017
    Event Type
    Death
    Date Received
    July 12, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 12, 2011
    Manufacturer
    INTEGRA, SAN DIEGO
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A CAMINO CATHETER 1104HM WAS INSERTED ON (B)(6) 2011, FOR THE PURPOSE OF INTRACRANIAL PRESSURE MONITORING DUE TO AN INTRACRANIAL BLEED. EIGHT MINUTES AFTER THE UNIT WAS INSERTED THE UNIT FAILED. THE CATHETER WAS REMOVED AND ANOTHER 1104HM WAS INSERTED. THE SECOND CATHETER FUNCTIONED WITHOUT INCIDENT. THE PT'S HISTORY INCLUDED HYPERTENSION WHICH RESULTED IN THE INTRACRANIAL BLEED. THE PT DIED ON (B)(6) 2011, SECONDARY TO THE INTRACRANIAL BLEED. THERE WAS NO RELATIONSHIP BETWEEN THE MALFUNCTIONING CATHETER AND THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO VENTRICULAR BOLT ICP MONITORING KIT NA GWM INTEGRA, SAN DIEGO 3050RY217633 PROBABLY

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death