BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 11074133 · Received December 27, 2020

    Report

    Report Number
    3013886523-2020-00279
    Event Type
    Malfunction
    Date Received
    December 27, 2020
    Date of Event
    November 14, 2020
    Report Date
    June 8, 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 MICROSENSOR WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT NUMBER 3943853 MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT HAS BEEN CONFIRMED. CATHETER STRETCHED 19CM FROM CONNECTOR. INTERNAL WIRES ARE BROKEN INSIDE CATHETER AT STRETCHED AREA. NO TESTING WAS POSSIBLE. THE CAUSE OF THE PROBLEM STATED TO BE 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 DURING THE MONITORING, THE MICROSENSOR SUDDENLY HAD NO SIGNAL AFTER VENTRICULAR PLACEMENT DURING PROCEDURE. THE PHYSICIAN STOP THE MONITORING. THERE WAS NO SURGICAL DELAY, AND NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538831 NEUROMONITOR BASIC KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 3943853

    Patients

    Seq Age Sex Outcome Treatment
    1