BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 15198870 · Received August 10, 2022

    Report

    Report Number
    3013886523-2022-00367
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 25, 2022
    Report Date
    February 2, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    UDI-DI
    10381780520412
    PMA / PMN Number
    K914479
    Product Problem
    Yes
    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 BASIC KIT (ID 826631) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR): THE PRODUCT 826631 FOR LOT 5190241 (SN A323956), AND THE LOT MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS: THE ISSUE OF THE COMPLAINT WAS NOT CONFIRMED. NO VISIBLE DAMAGE TO THE MILLAR SENSOR, CATHETER MATERIAL, AND CONNECTOR. ICP EXPRESS READING 407. 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 EXCESSIVE PRESSURE APPLIED TO PRODUCT.

    Description of Event or Problem · 0

    A FACILITY REPORTED A MICROSENSOR BASIC KIT (ID 826631) COULD NOT SHOW ICP READINGS. THE EVENT OCCURRED DURING PROCEDURE BEFORE IMPLANTATION SITE CLOSURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. . THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607137 NEUROMONITOR BASIC KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 826631 5190241 10381780520412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown