BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR 2 BRAIN PROBES

    MDR report key: 599621 · Received April 29, 2005

    Report

    Report Number
    9617494-2005-00012
    Event Type
    Malfunction
    Date Received
    April 29, 2005
    Report Date
    April 29, 2005
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY HAS HAD THREE OCCURENCES OF THE PMO FALLING OUT OF THE PT'S HEAD. ALL THREE BOLTS WERE PLACED IN THE SAME UNIT OF THE HOSP, TWO BY THE SAME RESIDENT AND ONE BY A DIFFERENT RESIDENT. ALL THREE BOLTS WERE IN PT BETWEEN 1/2 HOUR AND 2 HOURS, AND FELL OUT AFTER THE PT'S RETURNED FROM THEIR CT SCANS. THE DIRECTOR OF CLINICAL DEVELOPMENT HAS ONE OF THE BOLTS WITH THE CATHETERS STILL ATTACHED AVAILABLE FOR RETURN AND EVALUATION. ONE OF THE PT'S HAD AN ICP CATHETER INSERTED AFTER THE PMO CATHETER FELL OUT WHICH NECESSITATED A NEW BURR HOLE TO BE DRILLED. THE TWO ADDITIONAL INCIDENCES HAVE BEEN REPORTED AS MEDICAL DEVICE REPORT #961794-2005-00010 AND MEDICAL DEVICE REPORT 9617494-2005-00011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRODUCER KIT FOR 2 BRAIN PROBES LICOX DISPOSABLE GWM GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *