BEUDAMED
    FDA Adverse Event Death Summary report: N

    WISE CRT SYSTEM

    MDR report key: 23528205 · Received November 11, 2025

    Report

    Report Number
    3013596742-2025-00027
    Event Type
    Death
    Date Received
    November 11, 2025
    Date of Event
    October 17, 2025
    Report Date
    December 10, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    UDI-DI
    00859244007005
    PMA / PMN Number
    P240028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATTERY (S/N (B)(6)) AND TRANSMITTER (S/N (B)(6)) ASSOCIATED WITH THIS COMPLAINT REMAIN IMPLANTED; THEREFORE, VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A POSTOPERATIVE HEMATOMA DEVELOPED, WHICH IS A KNOWN POTENTIAL ADVERSE EVENT LISTED IN THE WISE CRT SYSTEM INSTRUCTIONS FOR USE (LBL-05300 REV B). REVIEW OF AVAILABLE DEVICE DATA, AND MANUFACTURING RECORDS FOR BOTH COMPONENTS CONFIRMED THAT THE DEVICES MET ALL SPECIFICATIONS, WITH NO MALFUNCTIONS, ANOMALIES, OR PERFORMANCE DEVIATIONS IDENTIFIED. THE REPORTED EVENT DOES NOT CORRESPOND TO ANY KNOWN DEVICE FAILURE MODE. BECAUSE HEMATOMA FORMATION IS PHYSIOLOGIC AND PATIENT-SPECIFIC, THE EVENT CANNOT BE REPRODUCED OR SIMULATED. NO EVIDENCE INDICATES THAT THE HEMATOMA OR THE PATIENT'S SUBSEQUENT VENTRICULAR FIBRILLATION ARREST WAS CAUSED BY, OR CONTRIBUTED TO BY, THE WISE CRT SYSTEM. MANUFACTURING RECORD REVIEWS FOR BOTH THE TRANSMITTER AND BATTERY REVEALED NO DISCREPANCIES. THE INVESTIGATION IDENTIFIED NO DEVICE-RELATED MALFUNCTION OR DEFECT. THE HEMATOMA IS CONSISTENT WITH KNOWN CLINICAL RISKS, AND THE PATIENT'S REFRACTORY VF ARREST AND SUBSEQUENT DEATH APPEAR UNRELATED TO THE SYSTEM.

    Additional Manufacturer Narrative · 0

    BASED ON CURRENT INFORMATION, THE PATIENT'S DEATH IS ASSESSED AS UNRELATED TO THE PERFORMANCE OF THE WISE CRT SYSTEM. THE POCKET HEMATOMA WAS MINOR, EXPECTED POST PROCEDURALLY, AND NOT CONTRIBUTORY TO THE CLINICAL DETERIORATION. THE EVENT IS MOST CONSISTENT WITH THE PATIENT';S UNDERLYING CARDIAC DISEASE AND MALIGNANT VENTRICULAR ARRHYTHMIA. THE INVESTIGATION REMAINS OPEN PENDING COMPLETION OF LOT HISTORY REVIEW AND ANY ADDITIONAL CLINICAL DATA. 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 A PATIENT WHO PREVIOUSLY UNDERWENT A BATTERY AND A TRANSMITTER (B&T) REPLACEMENT ON (B)(6) 2025, EXPERIENCED A FATAL VENTRICULAR FIBRILLATION (VF) EVENT. POST-OPERATIVELY, A LOCALIZED HEMATOMA WAS NOTED AT THE BATTERY POCKET; HOWEVER, IT REMAINED CONTROLLED AND WAS IMPROVING. A FEW DAYS AFTER THE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED AN EPISODE OF VF UNRELATED TO THE WISE CRT SYSTEM AND WAS TREATED WITH SHOCKS FROM THE CO-IMPLANTABLE ICD. DURING HOSPITALIZATION, LABORATORY VALUES SHOWED LOW POTASSIUM, AND CORRECTIVE TREATMENT WAS ADMINISTERED. ON (B)(6) 2025, THE PATIENT COLLAPSED WHILE ATTEMPTING TO USE THE BATHROOM AND WAS FOUND IN VF ARREST. MULTIPLE ICD SHOCKS WERE DELIVERED, BUT THE PATIENT REMAINED IN REFRACTORY VF. RESUSCITATION EFFORTS WERE UNSUCCESSFUL, AND THE PATIENT PASSED AWAY. AT THIS TIME, THERE IS NO INDICATION OF A MALFUNCTION OR PERFORMANCE ISSUE INVOLVING THE WISE CRT BATTERY OR TRANSMITTER THAT CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645170 WISE CRT SYSTEM MODEL 4100 SEG EBR SYSTEMS, INC. M4100 P250057 00859244007005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O