BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 2760222 · Received September 26, 2012

    Report

    Report Number
    1226348-2012-00473
    Event Type
    Injury
    Date Received
    September 26, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE NEUROSURGERY REGISTRAR INSERTED THE DEVICE TO MONITOR A PATIENTS INTRA CRANIAL PRESSURE. THE PATIENT HAD EXPERIENCED TRAUMA. THE ICP READING WAS IN THE 20S THEN THEY SUDDENLY ROSE TO 55MMHG. THE SURGEON DID NOT BELIEVE THESE TO BE CORRECT READINGS. A CT SCAN WAS PERFORMED ON THE PATIENT AND IT SHOWED SOME CHANGES. THE SURGEON REPLACED THE ICP SENSOR WITH ANOTHER SAME LIKE DEVICE. WHEN THE EVENT WAS REPORTED TO THE PRODUCT SPECIALIST THE FOLLOWING DAY, SHE WAS ABLE TO ZERO THE FAULTY MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN AND SHURTLEFF - MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention