BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIS

    MDR report key: 24973358 · Received April 23, 2026

    Report

    Report Number
    2936999-2026-00144
    Event Type
    Injury
    Date Received
    April 23, 2026
    Report Date
    April 28, 2026
    Manufacturer
    COVIDIEN LLC
    Product Code
    OLW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E1,G2 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: B5 CORRECTION: G3 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE MONITOR WAS UNRELIABLE. THE FILTER WAS DESELECTED TO AVOID OVERESTIMATION OF SEF, BUT STILL VERY UNSTABLE VALUES. ALSO, THE DSA WAS SHOWED AN ELEVATED SEF WHITE LINE. THE ANESTHETIC WAS ATTEMPTED TO DEEPEN WITH NO RESULTS (HIGH REMI, HIGH PROPOFOL AND EVEN ADDING SEVOFLURANE). THE MONITOR WAS REPLACED AND THE PATIENT WAS IN DEEP EEG SUPPRESSION BEYOND BURST SUPPRESSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE MONITOR WAS UNRELIABLE. THE FILTER WAS DESELECTED TO AVOID OVERESTIMATION OF SEF (SPECTRAL EDGE FREQUENCY), BUT STILL VERY UNSTABLE VALUES. ALSO, THE DSA (DENSITY SPECTRAL ARRAY) WAS SHOWED AN ELEVATED SEF WHITE LINE. THE ANESTHETIC WAS ATTEMPTED TO DEEPEN WITH NO RESULTS (HIGH REMI, HIGH PROPOFOL AND EVEN ADDING SEVOFLURANE). THE MONITOR WAS REPLACED AND THE PATIENT WAS IN DEEP EEG SUPPRESSION BEYOND BURST SUPPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569548 BIS INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR OLW COVIDIEN LLC PMB4000-CE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening