BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLM INTRACRANIAL PRESSURE

    MDR report key: 963873 · Received June 6, 2006

    Report

    Report Number
    2023988-2006-00019
    Event Type
    Death
    Date Received
    June 6, 2006
    Date of Event
    April 15, 2006
    Report Date
    June 6, 2006
    Manufacturer
    INTEGRA NEURO SCIENCES
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. THIS MEDICAL DEVICE REPORT IS LINKED TO MEDICAL DEVICE REPORT #2023988-2006-00020.

    Description of Event or Problem · 1

    INTEGRA MARKETING DIRECTOR MET THE DISTRIBUTOR REP AND WAS GIVEN 2 CAMINO CATHETERS THAT WERE REPORTED DEFECTIVE BY THE USER FACILITY. THE DEVICES WERE FORWARDED TO INTEGRA TECHNICAL SERVICE ON MAY 3, 2006. THE PROBES WERE USED IN 2 DIFFERENT PATIENTS. THE DATE OF INCIDENTS AND DATE INTEGRA WAS NOTIFIED WAS ON THE DATE OF EVENT FOR THE FIRST INCIDENT AND 04/06 FOR THE SECOND INCIDENT. THE CATHETERS WERE ZEROED BEFORE THEY WERE PLACED, WERE WORKING FINE AND STOPPED WORKING APPROX ONE HOUR LATER. THE PATIENTS DID NOT MOVE PRIOR TO THE CATHETERS NOT WORKING. THE CATHETERS WERE NOT REPLACED WHEN THE ORIGINALS WERE REMOVED; THE FACILITY DID NOT HAVE EXTRA CATHETERS, SO THEY DID NOT MONITOR THE PT AFTER THE FAILURE; ONE PT EXPIRED; THE PATIENT'S DEATH WAS NOT ATTRIBUTED TO THE DEVICE MALFUNCTION; THE 2ND PT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE ICP DISPOSABLES GWM INTEGRA NEURO SCIENCES * X050827

    Patients

    Seq Age Sex Outcome Treatment
    1 *