BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WISE CRT SYSTEM

    MDR report key: 23229148 · Received October 6, 2025

    Report

    Report Number
    3013596742-2025-00020
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 10, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    UDI-DI
    00859244007005
    PMA / PMN Number
    P240028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED TRANSMITTER (MODEL 4100, SN (B)(6)) AND BATTERY (MODEL 3100, SN (B)(6)) SHOWED NO GROSS KRYOFLEX RESIDUE, CORROSION, OR DELAMINATION. EXTERNAL WELDS, WIRE CONNECTIONS, AND SURFACES WERE INTACT WITH NO MECHANICAL DAMAGE TO EXPLAIN THE COMMUNICATION LOSS. A FAINT YELLOWISH DISCOLORATION WAS NOTED NEAR POLYMER INTERFACES, THOUGH NO VISIBLE LEAKAGE WAS CONFIRMED. FOLLOW-UP DATA FROM 23-NOV-2022 INDICATED A BATTERY VOLTAGE OF APPROXIMATELY 2.68 V, WITH THE VOLTAGE-BASED ALGORITHM ESTIMATING 27 % ENERGY REMAINING VERSUS 59 % BY THE ENERGY REMAINING COUNTER (ERC) A 22 % DISCREPANCY CONSISTENT WITH ABNORMAL CURRENT LEAKAGE AND ELEVATED PARASITIC DRAIN. THE VOLTAGE PROFILE SHOWED AN EARLY DROP FROM ~3.2 V TO 2.95 V, A PROLONGED PLATEAU NEAR 2.93 V, AND AN ACCELERATED DECLINE AFTER ~DAY 250, CHARACTERISTIC OF PARASITIC DRAW RATHER THAN NORMAL DISCHARGE BEHAVIOR. THE ABRUPT COMMUNICATION LOSS AND DEPLETION PATTERN ALIGN WITH PRIOR KRYOFLEX-RELATED CASES INVOLVING CONDUCTIVE MICRO-PATHS NEAR THE FEEDTHROUGH OR CONNECTOR INTERFACE. WHILE NO MACROSCOPIC POLYMER MIGRATION WAS EVIDENT, MICROSCOPIC RESIDUES BENEATH ENCAPSULATED REGIONS MAY HAVE CONTRIBUTED TO CURRENT LEAKAGE. ALTERNATIVE CAUSES SUCH AS END-OF-LIFE DEPLETION OR FIRMWARE LOCKUP WERE DEEMED UNLIKELY GIVEN SUFFICIENT RESIDUAL CAPACITY AT THE TIME OF FAILURE.

    Additional Manufacturer Narrative · 0

    THE BATTERY (B)(6) AND TRANSMITTER (B)(6) WERE RETURNED TO EBR FOR ANALYSIS. HOWEVER, THE INVESTIGATION HAS NOT YET BEEN COMPLETED. 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 THA 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 KNOWN OR UNAVAILABLE. EBR WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    THE BATTERY (S/N (B)(6)) AND TRANSMITTER (B)(6) WERE RETURNED TO EBR FOR ANALYSIS ON 03 OCOBTER 2025 HOWEVER INVESTIGATION IS STILL ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO EBR SYSTEMS AS OF THE DATE OF THIS SUBMISSION HAS BEEN INCLUDED IN THIS REPORT.

    Description of Event or Problem · 0

    A 77-YEAR-OLD MALE WITH A WISE CRT SYSTEM (IMPLANTED ON (B)(6) 2020, SOLVE STUDY) UNDERWENT TRANSMITTER AND BATTERY REPLACEMENT DUE TO PRIOR TRANSMITTER FAILURES (2021, 2022) AND LOSS OF DEVICE INTERROGATION SINCE 2022. THE PROCEDURE WAS UNCOMPLICATED, WITH CONSISTENT BIV PACING CONFIRMED POST-OP. FOLLOW-UP AND WOUND CARE ARE ONGOING. NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342942 WISE CRT SYSTEM M4100 SEG EBR SYSTEMS, INC. M4100 211008-03 00859244007005

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male