BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 13022346 · Received December 16, 2021

    Report

    Report Number
    3013886523-2021-00555
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 25, 2021
    Report Date
    October 12, 2022
    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

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10. THE MICROSENSOR (ID 826631) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT 826631 FOR LOT 5190240 (SN (B)(6)) AND THE LOT MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT HAS BEEN CONFIRMED. THE CATHETER MASHED/INDENTED 2CM FROM TIP. INTERNAL WIRES DAMAGED FROM BEING MASHED. ICP EXPRESS READ ¿NO TRANSDUCER DETECTED¿. NO TESTING WAS POSSIBLE. THE ROOT CAUSE COULD BE DETERMINED AS A MISHANDLING OF THE CATHETER.

    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 THAT DURING PRE-TESTING, THE MICROSENSOR COULD NOT BE DETECTED BY THE ICP MONITOR. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT. THE EVENT LED TO 10 MINUTES SURGICAL DELAY WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914262 NEUROMONITOR BASIC KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 826631 5107779 10381780520412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown