BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BOLT KIT

    MDR report key: 10687810 · Received October 15, 2020

    Report

    Report Number
    3013886523-2020-00155
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 24, 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 · 0

    THE MICROSENSOR WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE MICROSENSOR, PRODUCT CODE 82-6632 WITH LOT NUMBER 211726 (INCLUDING SERIAL NUMBER (B)(6)), CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON 6 SEP. 2018. UNIQUE DEVICE IDENTIFIER (UDI) : (B)(4). FAILURE ANALYSIS - BASED ON THE SUPPLIER ANALYSIS AND INVESTIGATION, THE ISSUE OF THE COMPLAINT WAS NOT CONFIRMED. NO VISIBLE DAMAGE TO THE MILLAR SENSOR, CATHETER, OR CONNECTOR; SLIGHT KINKS ALONG CATHETER MATERIAL. THE ICP EXPRESS READ 484. 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. THE MANUFACTURER'S PRODUCT DISPOSITION RECOMMENDATION IS "EVALUATE AND RETURN". HOWEVER, THE POSSIBLE ROOT CAUSE FOR "MALFUNCTION: NO TRANSDUCER DETECTED" REPORTED BY THE CUSTOMER COULD BE LINKED TO DEVICE USING ("INCORRECT SET-UP OF DEVICE" FOR EXAMPLE) AND/OR "EXCESSIVE FORCE APPLIED TO PRODUCT".

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT WHEN PERFORMING ZEROING OF THE MICROSENSOR, THE MONITOR SHOWED, "NO TRANSDUCER DETECTED." THERE WAS NO PATIENT INJURY AND NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152401 NEUROMONITOR BOLT KIT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 3293009

    Patients

    Seq Age Sex Outcome Treatment
    1