BEUDAMED
    FDA Adverse Event Death Summary report: N

    WISE CRT SYSTEM

    MDR report key: 23846291 · Received December 18, 2025

    Report

    Report Number
    3013596742-2025-00032
    Event Type
    Death
    Date Received
    December 18, 2025
    Date of Event
    November 5, 2025
    Report Date
    January 7, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    UDI-DI
    00859244007005
    PMA / PMN Number
    P240028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EBR SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. EBR 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, EBR, OR ITS EMPLOYEES THAT THE DEVICE, EBR, 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. EBR WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    THE MODEL 3100 BATTERY (S/N (B)(6)) AND MODEL 4100 TRANSMITTER (S/N (B)(6)) WERE NOT RETURNED FOR EVALUATION; THEREFORE, NO VISUAL INSPECTION OR FUNCTIONAL TESTING WAS PERFORMED. THE PRIMARY CAUSE OF DEATH WAS DOCUMENTED AS RESPIRATORY FAILURE. THE SITE DETERMINED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE WISE PROCEDURE, BATTERY, TRANSMITTER, ELECTRODE, OR SYSTEM FUNCTION. MANUFACTURING AND LOT HISTORY RECORDS CONFIRMED THAT BOTH DEVICES MET ALL ACCEPTANCE CRITERIA, WITH MINOR NONCONFORMANCES PREVIOUSLY REWORKED AND FOUND TO HAVE NO IMPACT ON SAFETY OR PERFORMANCE. BASED ON THE AVAILABLE INFORMATION, NO DEVICE-RELATED ROOT CAUSE WAS IDENTIFIED, AND THE EVENT IS ASSESSED AS A NON-DEVICE-RELATED CLINICAL OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT EXPERIENCED ACUTE HYPOXEMIC RESPIRATORY FAILURE (AHRF). EBR IS AWAITING COMPLETION OF THE CASE REPORT FORM (CRF) FROM THE CLINICAL SITE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 12/19/2025 INDICATED THAT THE PATIENT HAD PASSED AWAY. ACCORDING TO THE CLINICAL SITE, THE DEATH WAS CLASSIFIED AS NON-CARDIAC, WITH THE PRIMARY CAUSE OF DEATH BEING RESPIRATORY FAILURE. THERE WAS NO RELATIONSHIP IDENTIFIED BETWEEN THE REPORTED DEATH AND THE PROCEDURE OR THE WISE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239397 WISE CRT SYSTEM M4100 SEG EBR SYSTEMS, INC. M4100 P250203 00859244007005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O