BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 17996507 · Received October 24, 2023

    Report

    Report Number
    3013886523-2023-00371
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    October 5, 2023
    Report Date
    February 9, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MICROSENSOR (ID 826631) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT 826631 FOR LOT 6860121 (SN (B)(6) MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - CATHETER NYLON MASHED 1 CM FROM CASE. ICP EXPRESS READ 438. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS AND SIGNAL DRIFT TESTS. ROOT CAUSE ANALYSIS - THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE DEVICE WORKS CORRECTLY. HOWEVER, THE POSSIBLE ROOT CAUSE FOR THIS ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO INCORRECT SET UP OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A MICROSENSOR (ID 826631) COULD BE SUCCESSFULLY ZEROED AND WITH NORMAL CEREBROSPINAL FLUID (CSF) READINGS DURING THE PROCEDURE. HOWEVER, THE SENSOR SHOWED "P-0" AFTER THE PATIENT WAS SENT BACK TO THE WARD AND RECONNECTED WITH THE ICP EXPRESS, 220 VOLT (ID 826635). THEREFORE, THE SENSOR WAS REMOVED AND STOPPED THE MONITORING. THE CABLE USED WAS ICP EXPRESS CABLE (ID 826636). NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812560 NEUROMONITOR BASIC KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES MANSFIELD 6824400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ICP EXPRESS CABLE (ID 826636).| ICP EXPRESS, 220 VOLT (ID 826635