BEUDAMED
    FDA Adverse Event Death Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 22062790 · Received May 21, 2025

    Report

    Report Number
    3006544299-2025-00418
    Event Type
    Death
    Date Received
    May 21, 2025
    Date of Event
    May 12, 2025
    Report Date
    July 14, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OWB
    UDI-DI
    00763000709631
    PMA / PMN Number
    K200074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: M018081C001, VERSION #: 4.3.0. 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

    H3, H6: THE MANUFACTURE REPRESENTATIVE WENT TO THE SITE TO TEST THE IMAGING SYSTEM AND NO FAULT FOUND. MDR CODES: B01, C19, D14. H3: THE SOFTWARE INVESTIGATION FOUND THAT THIS WAS A CONFIRMED SOFTWARE ISSUE. MDR CODES: B01, C10, D02. 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 REVIEW OF THE EVENT AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A SPINAL FUSION CASE, THE SPINE SMART DOSE IMAGES APPEARED OVEREXPOSED. THE ANTERIOR PORTION OF THE VERTEBRAL BODY APPEARED WHITE AND CLINICAL CONSULTANT (CC) HAD TO ADJUST THE LEVEL AND WIDTH TO PROCEED WITH THE CASE. THEY TOOK A POST-OP HD SCAN WHICH HAD BETTER IMAGE QUALITY. CC NOTED THAT THE PATIENT HAD DIMINISHED ANATOMY DUE TO CANCER, AND THE PATIENT WAS HEAVY. THIS ISSUE OCCURRED INTRAOPERATIVELY AND DID NOT CAUSE ANY SURGICAL DELAY. ADDITIONAL INFORMATION STATING THAT THE CC REPORTED THAT WHEN THE SURGEON REMOVED THE FRAME FROM THE PATIENT, THE PATIENT CODED AND PASSED AWAY. CC WAS UNSURE HOW OR WHY THE PATIENT CODED. CC WAS NOT PRESENT WHEN THE PATIENT CODED, BUT CC BELIEVED THAT SPINE REPRESENTATIVE WAS IN THE VICINITY WHEN IT HAPPENED.

    Description of Event or Problem · 0

    ADDITIONAL REVIEW OF THE COMPLAINT INDICATED THAT BASED ON THE PROVIDED INFORMATION AND MEDICAL EXPERTISE, THE PATIENT'S DEATH WAS DETERMINED TO BE UNRELATED TO THE IMAGING SYSTEM AND SMART SPINE DOSE OVEREXPOSURE. THERE WAS NO REPORTED DELAY THAT EXPOSED THE PATIENT TO ADDITIONAL ANESTHESIA, NOR ANY DEVIATION FROM THE ORIGINALLY PLANNED SURGICAL APPROACH REQUIRING ADDITIONAL MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73141 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) BI70002000 00763000709631

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death "SEE H11...."