BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BOLT KIT

    MDR report key: 10841096 · Received November 14, 2020

    Report

    Report Number
    3013886523-2020-00207
    Event Type
    Malfunction
    Date Received
    November 14, 2020
    Report Date
    August 18, 2020
    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 · 1

    THE KIT WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR): LOT 4040101 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. UNIQUE DEVICE IDENTIFIER (UDI) : (B)(4). FAILURE ANALYSIS: THE ISSUE OF THE COMPLAINT WAS NOT CONFIRMED: NO VISIBLE DAMAGE TO THE SENSOR, CATHETER MATERIAL, OR CONNECTOR. THE DEVICE PASSED ELETRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. THE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER COULD BE DETERMINED AS THE DEVICE WORKED CORRECTLY. HOWEVER, THE POSSIBLE ROOT CAUSE OF THE DEFECT REPORTED BY THE CUSTOMER COULD BE DUE TO IMPROPER USE OR EXCESSIVE FORCE ON PRODUCT; PHYSICAL STRENGTH OF MATERIALS UNFIT FOR INTENDED USE.

    Description of Event or Problem · 1

    A FACILITY REPORTED MALFUNCTION OF THE NEUROMONITOR BOLT KIT. BEFORE PROCEDURE, THE DOCTOR WAS TRYING TO PERFORM THE ZEROING AND FOUND THIS SENSOR WAS NOT FUNCTIONING. THE MONITOR SHOWED THE MESSAGE: "NO TRANSDUCER DETECTED". NO PATIENT CONTACT/INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306356 NEUROMONITOR BOLT KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 4040101

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR