BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 15626120 · Received October 18, 2022

    Report

    Report Number
    3013886523-2022-00470
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 27, 2022
    Report Date
    February 3, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    UDI-DI
    10381780520412
    PMA / PMN Number
    K914479
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE MICROSENSOR (ID 826631) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT 826631 FOR LOT 5902139, AND THE LOT MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS: THE ISSUE OF THE COMPLAINT WAS NOT CONFIRMED. NO VISIBLE DAMAGE TO THE SENSOR, CATHETER MATERIAL, AND CONNECTOR. THE ICP EXPRESS READING 515. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. THE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER COULD NOT BE DETERMINED AS THE DEVICE WORKED CORRECTLY. HOWEVER, THE POSSIBLE ROOT CAUSE OF THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO INCORRECT SET-UP OF DEVICE.

    Description of Event or Problem · 0

    A FACILITY REPORTED A MICROSENSOR (ID 826631) WAS IMPLANTED ON AN UNKNOWN DATE AND SETTING. AFTER THE PATIENT RETURNED TO WARD, THE ICP READINGS WERE FLUCTUATING FROM 0-99MMHG. THEREFORE, THE MICROSENSOR WAS REMOVED ON (B)(6) 2022 AND STOP THE MONITORING.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265124 NEUROMONITOR BASIC KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 826631 5902139 10381780520412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown