BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WISE CRT SYSTEM

    MDR report key: 23931124 · Received December 30, 2025

    Report

    Report Number
    3013596742-2025-00039
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 10, 2025
    Report Date
    February 20, 2026
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    PMA / PMN Number
    P240028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 M5100 PROGRAMMER HAS NOT BEEN RETURNED TO EBR FOR EVALUATION, BUT THE INVESTIGATION REMAINS ONGOING. RESULTS AND CONCLUSIONS WITH ALL RELEVANT INFORMATION WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING IMPLANTATION OF THE WISE CRT SYSTEM, A PERSISTENTLY LOW COMMUNICATION SIGNAL WAS OBSERVED BETWEEN THE MODEL 5100 PROGRAMMER (S/N (B)(6)) AND THE IMPLANTED SYSTEM. THE PROGRAMMER RADIO MODULE WAS POSITIONED ADJACENT TO THE BATTERY POCKET, AND STANDARD TROUBLESHOOTING, INCLUDING REPOSITIONING AND POWER CYCLING, WAS PERFORMED; HOWEVER, THE LOW SIGNAL CONDITION PERSISTED THROUGHOUT THE PROCEDURE. COMMUNICATION REMAINED FUNCTIONAL BUT REQUIRED INTERMITTENT RECONNECTION. NO ERROR MESSAGES WERE DISPLAYED. THE IMPLANTATION PROCEDURE WAS COMPLETED SUCCESSFULLY. THE IMPLANTED MODEL 3100 BATTERY (S/N (B)(6)) AND MODEL 4100 TRANSMITTER (S/N (B)(6)) DELIVERED THERAPY AS INTENDED, AND CONSISTENT BIVENTRICULAR PACING WAS ACHIEVED. NO LOSS OF THERAPY, INTERRUPTION OF PACING, OR ADVERSE CLINICAL CONSEQUENCES WERE REPORTED. THE PROGRAMMER WAS NOT RETURNED FOR EVALUATION; THEREFORE, FUNCTIONAL TESTING AND FAILURE REPRODUCTION COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED LOW COMMUNICATION SIGNAL COULD NOT BE DETERMINED. THERE IS INSUFFICIENT EVIDENCE TO CONCLUDE WHETHER THE EVENT WAS RELATED TO PROGRAMMER RF PERFORMANCE, IMPLANT RF PERFORMANCE, OR ENVIRONMENTAL FACTORS. NO PATIENT INJURY OCCURRED, AND DEVICE THERAPY PERFORMANCE WAS NOT AFFECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXTREMELY LOW COMMUNICATION SIGNAL WAS OBSERVED WITH THE RADIO MODULE LOCATED DIRECTLY ADJACENT TO THE PATIENT BATTERY POCKET DURING THE ELECTRODE IMPLANTATION. NO ADDITIONAL DETAILS WERE PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE EBR REPRESENTATIVE ON 12/31/2025 INDICATING THAT THE LOW SIGNAL PERSISTED THROUGHOUT THE PROCEDURE AND REMAINED CONSTANT. STANDARD TROUBLESHOOTING MEASURES, INCLUDING REPOSITIONING AND POWER CYCLING (WITH NO SETTING CHANGES), WERE PERFORMED; HOWEVER, NO SIGNAL IMPROVEMENT WAS OBSERVED. THE PROCEDURE CONTINUED WITHOUT IMPACT TO IMPLANTATION OR PROGRAMMING, AND NO ERROR MESSAGES WERE NOTED. THE ONLY IMPACT OF THE LOW SIGNAL WAS THE NEED TO RECONNECT THE DEVICE DURING THE CASE. THE PATIENT OUTCOME WAS CONSISTENT WISE BI-V PACING. NO FURTHER DEATILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114829 WISE CRT SYSTEM M5100 SEG EBR SYSTEMS, INC. MODEL 5100 P250049

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown