BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WISE CRT SYSTEM

    MDR report key: 23662994 · Received November 26, 2025

    Report

    Report Number
    3013596742-2025-00035
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 18, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    UDI-DI
    12080396306
    PMA / PMN Number
    P240028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED CONCERNING MODEL 5100 PROGRAMMER (S/N (B)(6). THE ISSUE OCCURRED WHEN THE USER INTERFACE (UI) BECAME PARTIALLY UNUSABLE FOLLOWING A SCREEN ORIENTATION CHANGE FROM LANDSCAPE TO PORTRAIT MODE. WHEN THE SCREEN WAS RETURNED TO LANDSCAPE ORIENTATION, APPROXIMATELY HALF OF THE SCREEN BECAME BLACK/UNUSABLE, WHICH OBSTRUCTED USER INTERACTION (INCLUDING ACCESS TO THE "PROGRAM" BUTTON). THE PROGRAMMER REQUIRED TWO RESTARTS TO RECOVER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, FUNCTIONAL TESTING OF THE ACTUAL UNIT COULD NOT BE PERFORMED. A PHOTOGRAPH PROVIDED BY THE FIELD REPRESENTATIVE CONFIRMED THAT A PORTION OF THE DISPLAY WAS RENDERED BLACK AND UNUSABLE FOLLOWING THE ORIENTATION CHANGE. THE ISSUE WAS RESOLVED IN THE FIELD BY RESTARTING THE PROGRAMMER. THE BEHAVIOR WAS SUBSEQUENTLY REPRODUCED IN-HOUSE USING AN INTERNAL PROGRAMMER UNIT. A MANUFACTURING REVIEW WAS CONDUCTED, INCLUDING A REVIEW OF THE LOT HISTORY RECORDS FOR BOTH THE PROGRAMMER AND THE ASSOCIATED COMMUNICATION MODULE. THE REVIEW CONFIRMED THAT THE DEVICE WAS MANUFACTURED, TESTED, AND RELEASED IN ACCORDANCE WITH APPROVED PROCEDURES. ALL IN-PROCESS AND FINAL TEST RESULTS MET ESTABLISHED SPECIFICATIONS, AND NO MANUFACTURING NONCONFORMANCES WERE IDENTIFIED THAT COULD BE ASSOCIATED WITH THE REPORTED ISSUE. THE ROOT CAUSE WAS DETERMINED TO BE A SOFTWARE USER-INTERFACE LAYOUT DEFECT. SPECIFICALLY, THE UI DOES NOT PROPERLY REFLOW OR RECOVER DURING SCREEN ORIENTATION CHANGES WHEN AUTOMATIC ROTATION IS ENABLED. UNDER THESE CONDITIONS, THE PROGRAMMER MAY TEMPORARILY RESTRICT ACCESS TO CERTAIN UI FUNCTIONS UNTIL THE DEVICE IS RESTARTED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHECK ON (B)(6) 2025, THE MODEL 5100 PROGRAMMER EXPERIENCED A RECURRING DISPLAY MALFUNCTION PRIOR TO CONNECTING TO THE PATIENT'S WISE CRT SYSTEM. WHEN THE PROGRAMMER WAS INADVERTENTLY ROTATED INTO PORTRAIT ORIENTATION AND THEN RETURNED TO LANDSCAPE, THE SCREEN PARTIALLY BLACKED OUT, RENDERING APPROXIMATELY HALF OF THE DISPLAY UNUSABLE. MULTIPLE SYSTEM RESTARTS WERE REQUIRED TO RESTORE NORMAL FUNCTIONALITY. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2728856 WISE CRT SYSTEM M5100 SEG EBR SYSTEMS, INC. M5100 P250186 12080396306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown