BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 16159187 · Received January 13, 2023

    Report

    Report Number
    3013886523-2023-00003
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 28, 2022
    Report Date
    June 23, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    UDI-DI
    10381780520412
    PMA / PMN Number
    K914479
    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

    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 6042365 (SN (B)(6), 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 OR CONNECTOR. THE ICP EXPRESS READ 487. 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 DEFECT REPORTED BY THE CUSTOMER COULD BE DUE TO INCORRECT SET UP OF THE DEVICE. .

    Description of Event or Problem · 0

    A FACILITY REPORTED A MICROSENSOR (ID 826631) WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, THE MICROSENSOR ICP READINGS SUDDENLY BECAME ABNORMAL WITH ICP READING OF -99MMHG. THEN THE PHYSICIAN RETRIEVED THE MICROSENSOR AND STOP MONITORING.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464647 NEUROMONITOR BASIC KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 826631 6042364 10381780520412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CABLE: ID 826636| MONITOR: ID 826635