BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL

    MDR report key: 671256 · Received September 9, 2005

    Report

    Report Number
    2023988-2005-00038
    Event Type
    Malfunction
    Date Received
    September 9, 2005
    Report Date
    September 9, 2005
    Manufacturer
    INTEGRA NEURO SCIENCES
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO PROBES WERE USED ON THE SAME PT. A NEUROSENSOR PROBE WAS IMPLANTED IN 2005. THERE WERE NO CBF READINGS, SO THE PHYSICIAN REMOVED THE PROBE AND INSERTED ANOTHER PROBE. THE SECOND PROBE DID NOT PROVIDE CBF READINGS EITHER. THE PHYSICIAN TRIED ROTATING THE CATHETER. IT WAS REPORTED THAT THE PT WAS IN VERY POOR HEALTH AND EXPIRED THE NEXT DAY. TWO PROBES WERE PLACED IN THE SAME PT IN WHICH THE NEUROSURGEON HAD READINGS OF 0-2CC/100GM/MIN. THE PHYSICIAN ATTRIBUTED THE READINGS IN THE PT AS DUE TO THE PT'S POOR MEDICAL CONDITION IN THAT THE PT WAS NEAR BRAIN DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL NEUROSENSOR DPW INTEGRA NEURO SCIENCES * W050980

    Patients

    Seq Age Sex Outcome Treatment
    1 *