BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 11784823 · Received May 6, 2021

    Report

    Report Number
    3013886523-2021-00206
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 15, 2021
    Report Date
    September 26, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4)/(B)(4). COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    THE CODMAN BASIC KIT MICROSENSOR WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - PRODUCT 826631 FOR LOT NUMBER 4251056 (SERIAL NUMBER (B)(6)) MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - BASED ON THE SUPPLIER ANALYSIS AND INVESTIGATION, THE ISSUE OF THE COMPLAINT HAS BEEN CONFIRMED. VERIFIED CATHETER SENSOR TORN OFF FROM CATHETER. ICP EXPRESS READ "NO TRANSDUCER DETECTED". NO TESTING WAS POSSIBLE BASED ON THE FAILURE ANALYSIS, THE ROOT CAUSE OF THE PROBLEM STATED COULD BE DETERMINED TO BE MISHANDLING OF THE CATHETER. THE CATHETER MUST BE SEALED (NO OPENINGS) IN ORDER TO MEET MILLAR'S TESTING SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 0

    N/A.

    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 PHYSICIAN REPORTED THAT THE CODMAN BASIC KIT MICROSENSOR WAS RUPTURED DUE TO BONE PASTE BEING PLACED WHERE THE ICP SENSOR WAS PLACED AND THE SOLIDIFIED PART WAS PULLED. IT WAS TORN OFF WHEN ATTEMPTING THE REMOVAL AND REMAINED. THEREFORE, THE MICROSENSOR WAS REMOVED. ANOTHER PRODUCT WAS USED FOR THE PROCEDURE. NO SURGICAL DELAY WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679395 NEUROMONITOR BASIC KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 4251056

    Patients

    Seq Age Sex Outcome Treatment
    1