BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WISE CRT SYSTEM

    MDR report key: 24918629 · Received April 17, 2026

    Report

    Report Number
    3013596742-2026-00022
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 13, 2026
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    UDI-DI
    00859244007043
    PMA / PMN Number
    P240028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, BIVENTRICULAR (BIV) PACING WAS COMPLETELY ABSENT ON THE TABLE FOLLOWING ELECTRODE DEPLOYMENT. EXTENSIVE INTRA-PROCEDURAL TROUBLESHOOTING WAS PERFORMED IN ACCORDANCE WITH BEST PRACTICE GUIDANCE, INCLUDING EVALUATION FOR NOISE, ADJUSTMENTS TO TRANSMIT LEVEL (TL) AND PULSE WIDTH, GLOBAL SEARCH CENTER OPTIMIZATION, SENSOR TESTING, PATIENT REPOSITIONING, BREATH-HOLD MANEUVERS, AND POCKET MANIPULATION. DESPITE THESE EFFORTS, NO TRACKING WAS ACHIEVED WITH ANY SENSOR EXCEPT THE VERTICAL SENSOR, WHICH DEMONSTRATED CONSISTENT TRACKING WHEN ENABLED. EDGE MEASUREMENTS REMAINED STABLE AT 1.000 THROUGHOUT, WITH NO INDICATION OF NOISE, AND RV PACE DETECTION WAS CONSISTENT WITH NO CO-IMPLANT SENSING ISSUES. ACOUSTIC WINDOW LIMITATIONS WERE SUSPECTED, SPECIFICALLY POTENTIAL AIR IN THE TRANSMITTER POCKET. NO ADDITIONAL PROGRAMMING CHANGES WERE REQUIRED POST-OPERATIVELY BEYOND RESTRICTING SENSING TO THE VERTICAL SENSOR, AND CONSISTENT BIV PACING WAS SUBSEQUENTLY OBSERVED POST-OP.NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186882 WISE CRT SYSTEM M1000 SEG EBR SYSTEMS, INC. M1000 P250295 00859244007043

    Patients

    Seq Age Sex Outcome Treatment
    1