BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WISE CRT SYSTEM

    MDR report key: 23819344 · Received December 16, 2025

    Report

    Report Number
    3013596742-2025-00038
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    December 3, 2025
    Report Date
    February 5, 2026
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    PMA / PMN Number
    P240028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MODEL 3100 BATTERY (S/N (B)(6)) AND MODEL 4100 PULSE GENERATOR (S/N (B)(6)) ASSOCIATED WITH THIS COMPLAINT WERE NOT RETURNED TO EBR; THEREFORE, DIRECT VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED AS PART OF THE INVESTIGATION. IN LIEU OF RETURNED PRODUCT ANALYSIS, PROGRAMMER LOGS AND BATTERY VOLTAGE CURVES WERE REVIEWED. ANALYSIS OF THE VOLTAGE CURVE IDENTIFIED ABNORMAL VOLTAGE INSTABILITY INCONSISTENT WITH EXPECTED PERFORMANCE FOR A NEWLY REPLACED BATTERY. SPECIFICALLY, BETWEEN DAY 5 AND DAY 50 POST-REPLACEMENT, THE BATTERY EXHIBITED VOLTAGE SWINGS OF APPROXIMATELY 0.1 V, WHICH IS NOT EXPECTED DURING EARLY BATTERY LIFE. ADDITIONAL VOLTAGE FLUCTUATIONS OF APPROXIMATELY 0.15 V WERE OBSERVED AROUND DAYS 75, 115, 175, AND 200. THESE VOLTAGE VARIATIONS EXCEED NORMAL BATTERY AGING CHARACTERISTICS AND ARE NOT CONSISTENT WITH EXPECTED LOAD-RELATED VOLTAGE BEHAVIOR. THE OBSERVED PATTERN OF PRONOUNCED VOLTAGE INSTABILITY IS INDICATIVE OF EXCESS INTERNAL CURRENT DRAW. THIS FAILURE SIGNATURE IS CONSISTENT WITH PREVIOUSLY DOCUMENTED CASES INVOLVING DENDRITIC GROWTH ACROSS THE BATTERY AND KRYOFLEX FEEDTHROUGH INSULATOR. DENDRITIC FORMATION CAN CREATE UNINTENDED CONDUCTIVE PATHWAYS, RESULTING IN LEAKAGE CURRENT, INCREASED CURRENT CONSUMPTION, AND UNSTABLE VOLTAGE BEHAVIOR. AS THE MODEL 4100 TRANSMITTER WAS NOT RETURNED FOR ANALYSIS, THE ROOT CAUSE COULD NOT BE CONFIRMED. HOWEVER, THE TRANSMITTER'S SERIAL NUMBER FALLS WITHIN THE SCOPE OF CAPA 20-001, WHICH WAS INITIATED TO ADDRESS FEEDTHROUGH FAILURES.

    Additional Manufacturer Narrative · 0

    THE MODEL 3100 BATTERY (S/N (B)(6)) AND MODEL 4100 TRANSMITTER (S/N (B)(6)) WERE NOT RETURNED TO EBR FOR ANALYSIS AND WILL NOT BE EXPLANTED, AS BOTH DEVICES REMAIN IMPLANTED IN THE PATIENT. THE INVESTIGATION IS CURRENTLY ONGOING AND IS BEING CONDUCTED THROUGH REVIEW OF AVAILABLE BATTERY CURVES, PROGRAMMER LOGS, AND LOT HISTORY RECORDS. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    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 FOLLOW-UP FOR AN EX-SOLVE PATIENT, THE WISE CRT SYSTEM WAS FOUND TO BE OPERATIONAL; HOWEVER, THE IMPLANTED WISE BATTERY DEMONSTRATED AN ABNORMAL AND NOISY BATTERY VOLTAGE CURVE. THE PATIENT HAD UNDERGONE A ROUTINE WISE BATTERY REPLACEMENT IN (B)(6) 2025, AND AT A SUBSEQUENT DEVICE CHECK IN (B)(6) 2025, ABNORMAL NOISE ON THE BATTERY CURVE WAS ALREADY EVIDENT. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943576 WISE CRT SYSTEM M4100 SEG EBR SYSTEMS, INC. M4100 102318-04

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown