BEUDAMED
    FDA Adverse Event Death Summary report: N

    WISE CRT SYSTEM, INC.

    MDR report key: 23662920 · Received November 26, 2025

    Report

    Report Number
    3013596742-2025-00034
    Event Type
    Death
    Date Received
    November 26, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 22, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    PMA / PMN Number
    P240028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATTERY AND TRANSMITTER WERE NOT RETURNED FOR ANALYSIS, PREVENTING FUNCTIONAL TESTING, THOUGH REVIEW OF PROGRAMMER LOGS INDICATED THAT AS OF ON (B)(6) 2025, BATTERY (B)(6) HAD APPROXIMATELY 8% REMAINING ENERGY. UNDER NORMAL CONDITIONS, EVEN AT END-OF-SERVICE, THE WISE TRANSMITTER IS EXPECTED TO MAINTAIN BASIC RADIO COMMUNICATION, MAKING THE COMPLETE LOSS OF COMMUNICATION INCONSISTENT WITH NORMAL EOS BEHAVIOR. WHILE THE LAST BATTERY VOLTAGE APPEARED NORMAL, IT WAS MEASURED EIGHT MONTHS PRIOR, AND RAPID PROGRESSION OF CURRENT-LEAKAGE ISSUES ASSOCIATED WITH FSN 20-001 KYROFLEX FEED THROUGH MECHANISMS IS POSSIBLE. LOT HISTORY RECORD REVIEW CONFIRMED THAT ALL MANUFACTURING, INSPECTION, LABELING, TRACEABILITY, AND STERILIZATION PROCEDURES FOR THE TRANSMITTER AND BATTERY WERE COMPLETE AND COMPLIANT, WITH NO NONCONFORMANCE'S IDENTIFIED. THE OBSERVED RV-ONLY PACING AND INABILITY TO COMMUNICATE SUPPORT A PRIMARY SYSTEM POWER FAILURE RATHER THAN AN INDEPENDENT PACING OR ELECTRODE MALFUNCTION. THE COMPLAINT IS THEREFORE CONFIRMED AS LOSS OF BIV PACING DUE TO WISE POWER SYSTEM FAILURE, MOST CONSISTENT WITH COMPLETE BATTERY DEPLETION. BATTERY DEPLETION MAY HAVE BEEN ACCELERATED BY KNOWN KYROFLEX FEED THROUGH-RELATED CURRENT LEAKAGE ASSOCIATED WITH FSN 20-001. THE EXACT MECHANISM CANNOT BE CONFIRMED WITHOUT RETURNED HARDWARE.

    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. EBR WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    THE PATIENT'S DISCHARGE LETTER WAS RECEIVED, INDICATING SHE WAS DISCHARGED ON (B)(6) 2025 WITH HEART FAILURE DUE TO DILATED CARDIOMYOPATHY AND PERMANENT ATRIAL FIBRILLATION, ALONG WITH CHRONIC KIDNEY DISEASE, TYPE 2 DIABETES, AND CHRONIC SKIN PROBLEMS ON THE LEGS. THE PATIENT ALSO HAD A HISTORY OF INFECTIONS, PERIPHERAL ARTERY DISEASE WITH PREVIOUS AORTIC SURGERY, AND PULMONARY NODULES.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025, THAT THE PATIENT WAS EVALUATED BY THE TREATING PHYSICIAN DUE TO FLUID RETENTION REQUIRING INTRAVENOUS DIURETICS. DURING THIS VISIT, THE PRESENTING ECG SHOWED RV-ONLY PACING, PROMPTING IMMEDIATE ASSESSMENT OF THE WISE CRT SYSTEM. THE PHYSICIAN ATTEMPTED SYSTEM INTERROGATION; HOWEVER, NO COMMUNICATION COULD BE ESTABLISHED WITH THE WISE TRANSMITTER OR THE CO-IMPLANTED DEVICE, AND BIV CAPTURE COULD NOT BE ASSESSED OR ACHIEVED. THE PATIENT HAD BEEN HOSPITALIZED IN LATE SEPTEMBER FOR WORSENING HEART FAILURE AND WAS ONLY RECENTLY DISCHARGED, WHICH PREVENTED THE PLANNED WISE SYSTEM FOLLOW-UP IN (B)(6). A BATTERY REPLACEMENT PROCEDURE HAD BEEN SCHEDULED FOR (B)(6) 2025; HOWEVER, ON 26-NOVEMBER-2025, EBR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT SUBSEQUENTLY PASSED AWAY. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753471 WISE CRT SYSTEM, INC. M4100 SEG EBR SYSTEMS, INC. M4100 102318-04

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death