BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICB/CBF PARACH PROBE

    MDR report key: 664312 · Received September 15, 2005

    Report

    Report Number
    2023988-2005-00042
    Event Type
    Malfunction
    Date Received
    September 15, 2005
    Report Date
    September 15, 2005
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THREE INCIDENTS INVOLVING THREE SEPARATE PTS WERE REPORTED BY THIS USER FACILITY. USER FACILITY REPORTED THAT AFTER THE PROBE WAS INSERTED AND WHILE THE PT WAS IN TRANSIT FOR A CT SCAN, THE CATHETER CONNECTOR DISCONNECTED, FELL TO THE GROUND AND WAS STEPPED ON, RESULTING IN IT BREAKING. MONITORING WAS UNABLE TO BE CONTINUED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS MEDICAL DEVICE REPORT IS LINKED TO MEDICAL DEVICE REPORT #2023988-2005-00044 AND #2023988-2005-00045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICB/CBF PARACH PROBE NEUROSENSOR DPW INTEGRA NEUROSCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *