BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSENSOR KIT W/ SKULL BOLT

    MDR report key: 15858614 · Received November 23, 2022

    Report

    Report Number
    3013886523-2022-00550
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    October 19, 2022
    Report Date
    March 9, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    UDI-DI
    20886704042386
    PMA / PMN Number
    K914479
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    THE MICROSENSOR (ID 826638) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 3943861 (SN (B)(6)) 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 500. 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 PF THE ISSUE REPORTED BY CUSTOMER COULD PROBABLY BE DUE TO AN INCORRECT SET-UP OF DEVICE.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT A MICROSENSOR KIT W/ SKULL BOLT (ID 826638) WAS IMPLANTED ON (B)(6) 2022. AFTER INSTALLING THE SENSOR, THE MONITOR DISPLAYED "-99", MAKING IT IMPOSSIBLE TO MEASURE ACCURATELY. THE MICROSENSOR WAS REMOVED, AND ANOTHER PRODUCT WAS USED AND COMPLETED. IT IS UNKNOWN WHICH MONITOR AND CABLE WERE USED. IT IS UNKNOWN IF THE EVENT LEAD TO AN INCREASE IN SURGERY TIME; HOWEVER, NO PATIENT INJURY OR DEATH OCCURRED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686485 MICROSENSOR KIT W/ SKULL BOLT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 82-6638 20886704042386

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown