BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WISE CRT SYSTEM

    MDR report key: 23927403 · Received December 30, 2025

    Report

    Report Number
    3013596742-2025-00043
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 16, 2025
    Report Date
    May 13, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    PMA / PMN Number
    P240028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EBR IS CURRENTLY VERIFYING THE SHIPMENT AND RECEIPT STATUS OF THE EXPLANTED DEVICES TO CONFIRM RETURN TO EBR FOR ANALYSIS. THE INVESTIGATION REMAINS ONGOING PENDING CONFIRMATION OF DEVICE RECEIPT AND, IF APPLICABLE, COMPLETION OF PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON CONFIRMATION OF RECEIPT AND/OR COMPLETION OF THE ANALYSIS.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REMAINS ONGOING. THE DEVICE WAS INITIALLY SHIPPED FOR RETURN; HOWEVER, THE SHIPMENT WAS HELD BY CUSTOMS DUE TO A MISSING COMMERCIAL INVOICE AND WAS SUBSEQUENTLY RETURNED TO THE SENDER. ARRANGEMENTS ARE BEING MADE TO RESHIP THE DEVICE FOR RETURN AND EVALUATION. THE INVESTIGATION WILL REMAIN OPEN PENDING CONFIRMATION OF DEVICE RECEIPT AND COMPLETION OF PRODUCT EVALUATION, IF APPLICABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THE DEVICE IS RECEIVED AND THE ANALYSIS IS COMPLETED, OR IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MANUFACTURER INCIDENT REPORT, IT WAS STATED THAT THE EXPLANTED BATTERY (S/N (B)(6) AND TRANSMITTER (S/N (B)(6) HAD BEEN RETURNED TO EBR FOR ANALYSIS. IT WAS LATER DETERMINED THAT THESE DEVICES HAD NOT BEEN RECEIVED BY EBR. INSTEAD, THE DEVICES WERE RETURNED TO HLE IN THE NETHERLANDS RATHER THAN SHIPPED DIRECTLY TO EBR. THE DEVICES ARE EXPECTED TO BE RETURNED TO EBR FOR ANALYSIS. THE INVESTIGATION REMAINS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS INCIDENT OCCURRED OUTSIDE THE USA. THE WISE CRT TRANSMITTER (S/N (B)(6)) AND BATTERY (S/N (B)(6)) WERE RETURNED TO EBR FOR ANALYSIS. THE INVESTIGATION IS ONGOING, AND RESULTS WILL BE PROVIDED UPON COMPLETION. 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 ON (B)(6) 2025, THAT THE PATIENT UNDERWENT A BATTERY AND TRANSMITTER REPLACEMENT. THE BATTERY POCKET WAS REOPENED VIA THE ORIGINAL INCISION, AND THE BATTERY WAS EASILY REMOVED. THE TRANSMITTER POCKET WAS OPENED USING DIATHERMY, WITH DISSECTION CARRIED OUT TO EXPOSE THE ANTERIOR SURFACE OF THE TRANSMITTER. TUNNELING PROVED DIFFICULT DUE TO FIBROSIS NEAR THE BATTERY POCKET. DESPITE A RECOMMENDATION FROM THE EBR REPRESENTATIVE TO CREATE A NEW TUNNEL USING THE OLD CABLE AS A GUIDE, THE PHYSICIAN ATTEMPTED TO PRESERVE THE EXISTING TUNNEL. DURING TRACTION FROM THE TRANSMITTER POCKET, THE CABLE WAS DAMAGED. A NEW TUNNEL WAS SUBSEQUENTLY CREATED, AND A NEW TRANSMITTER CABLE WAS ROUTED TO THE BATTERY POCKET AND TEMPORARILY CONNECTED TO THE OLD BATTERY WHILE AWAITING THE NEW BATTERY. THE BATTERY WAS REPLACED LATER THAT DAY. NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319907 WISE CRT SYSTEM M4100 SEG EBR SYSTEMS, INC. M4100 EJ00003601

    Patients

    Seq Age Sex Outcome Treatment
    1