BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 11791629 · Received May 7, 2021

    Report

    Report Number
    3013886523-2021-00205
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    April 10, 2021
    Report Date
    July 15, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MCROSENSOR WAS RETURNED FRO EVALUATION: DEVICE HISTORY RECORD (DHR) - SERIAL NUMBER (B)(6) (LOT # 3943843) CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT HAS BEEN CONFIRMED. TIP OF THE CATHETER, CASE AND SENSOR CUT/TORN OFF. THE ICP EXPRESS READ ¿NO TRANSDUCER DETECTED¿. NO TESTING WAS POSSIBLE BASED ON THE FAILURE ANALYSIS, THE ROOT CAUSE COULD BE DETERMINED AS A MISHANDLING OF THE CATHETER.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    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 · 1

    A FACILITY REPORTED THAT AFTER UNPACKING THE MICROSENSOR, IT WAS FOUND THAT THE TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT. NO PATIENT CONTACT/INJURY AND NO SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686573 NEUROMONITOR BASIC KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 3943845

    Patients

    Seq Age Sex Outcome Treatment
    1