BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WISE CRT SYSTEM

    MDR report key: 23858062 · Received December 19, 2025

    Report

    Report Number
    3013596742-2025-00041
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    December 11, 2025
    Report Date
    April 11, 2026
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    UDI-DI
    00859244007043
    PMA / PMN Number
    P240028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THIS CASE IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING, AND ADDITIONAL INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    EBR SYSTEMS CONDUCTED AN INVESTIGATION OF THE REPORTED EVENT INVOLVING MODEL 1000 ELECTRODE CATHETERS (S/N (B)(6); LOT P250144). ACCORDING TO THE CLINICAL REPORT, MULTIPLE LEFT VENTRICULAR IMPLANT LOCATIONS WERE EVALUATED; HOWEVER, ELEVATED PACING THRESHOLDS WERE OBSERVED AT SEVERAL SITES, AND CAPTURE COULD NOT BE RELIABLY MAINTAINED DESPITE ACCEPTABLE DISTANCE AND ANGLE PARAMETERS. MYOCARDIAL STAINING WAS OBSERVED DURING THE PROCEDURE WITHOUT EVIDENCE OF PERICARDIAL EFFUSION OR HEMODYNAMIC COMPROMISE. THE PROCEDURE WAS DISCONTINUED DUE TO PERSISTENTLY ELEVATED PACING THRESHOLDS AND PROCEDURAL CONSIDERATIONS. THE PATIENT REMAINED CLINICALLY STABLE AND WAS DISCHARGED WITHOUT COMPLICATION. THE DEVICES INVOLVED IN THE PROCEDURE WERE NOT RETURNED TO EBR SYSTEMS; THEREFORE, VISUAL INSPECTION AND FUNCTIONAL PERFORMANCE TESTING COULD NOT BE PERFORMED AND THE REPORTED CONDITION COULD NOT BE REPRODUCED. A REVIEW OF THE MANUFACTURING DOCUMENTATION, INCLUDING THE LOT HISTORY RECORDS FOR MODEL 1000 ELECTRODE CATHETER S/N (B)(6) (LOT P250144), AND ASSOCIATED SUBASSEMBLIES WAS CONDUCTED. SEVERAL NCRS ASSOCIATED WITH RELATED MANUFACTURING LOTS WERE IDENTIFIED DURING THE REVIEW; HOWEVER, THE SPECIFIC SERIAL NUMBERS INVOLVED IN THIS EVENT MET ALL ACCEPTANCE CRITERIA AND WERE NOT AFFECTED BY THE IDENTIFIED NONCONFORMANCES. NO DISCREPANCIES OR MANUFACTURING ANOMALIES WERE IDENTIFIED THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, NO EVIDENCE OF DEVICE MECHANICAL OR ELECTRICAL MALFUNCTION WAS IDENTIFIED. THE SPECIFIC CAUSE OF THE ELEVATED PACING THRESHOLDS COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THIS EVENT OCCURRED OUTSIDE THE USA. THE MODEL M1000 ELECTRODE AND DELIVERY CATHETERS T05170 AND T05551 WILL NOT BE RETURNED TO EBR FOR ANALYSIS. THEREFORE, CLINICAL DATA, MANUFACTURING RECORDS, AND PRODUCT LABELING WILL BE REVIEWED AS PART OF THE INVESTIGATION PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS REVIEW. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 15 FEBRUARY 2026 INDICATING THAT THE NEXT IMPLANTATION ATTEMPT IS SCHEDULED FOR (B)(6) 2026. THE EBR REPRESENTATIVE REPORTED THAT THE PHYSICIAN ROUTINELY PERFORMS TRANSSEPTAL ACCESS USING A 12F MEDTRONIC FLEXCATH CONTOUR SHEATH WITH RELIABLE PROCEDURAL SUCCESS. DURING THIS CASE, ADVANCEMENT OF THE DELIVERY SHEATH (DS) THROUGH THE FLEXCATH SHEATH WAS UNSUCCESSFUL DESPITE STANDARD MANIPULATION TECHNIQUES. AS A RESULT, THE FLEXCATH SHEATH WAS EXCHANGED FOR A 13F BOSTON SCIENTIFIC FARADRIVE SHEATH, WHICH ENABLED SUCCESSFUL CONTINUATION OF THE PROCEDURE. FOR THE FUTURE IMPLANTATION ATTEMPT, CONSIDERATION WILL BE GIVEN TO THE USE OF A 13F ABBOTT AGILIS NXT DUAL REACH 71 CM LARGE CURL INTRODUCER TO POTENTIALLY FACILITATE IMPROVED DEVICE DELIVERY AND SEPTAL ALIGNMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LEADLESS LEFT VENTRICULAR PACING PROCEDURE WAS ATTEMPTED ON (B)(6) 2025 USING THE WISE CRT SYSTEM. SYSTEM FUNCTIONALITY AND TRACKING WERE CONFIRMED FOLLOWING ELECTRODE INSERTION. MULTIPLE LEFT VENTRICULAR SEPTAL SITES WERE EVALUATED; HOWEVER, MOST DEMONSTRATED ELEVATED PRE-ANCHOR PACING THRESHOLDS AND WERE DEEMED UNSUITABLE. ONE BASAL INFEROSEPTAL SITE EXHIBITED AN ACCEPTABLE PRE-ANCHOR PACING THRESHOLD. AFTER ANCHORING, THE PACING THRESHOLD INCREASED AND CONTINUED TO RISE, ULTIMATELY RESULTING IN LOSS OF CAPTURE. THE PROCEDURE WAS TERMINATED DUE TO PERSISTENTLY HIGH PACING THRESHOLDS, EVIDENCE OF MYOCARDIAL STAINING, AND CUMULATIVE RADIATION EXPOSURE APPROACHING INSTITUTIONAL SAFETY LIMITS. NO DEVICE MALFUNCTION OR MECHANICAL FAILURE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510316 WISE CRT SYSTEM M1000 SEG EBR SYSTEMS, INC. M1000 P250144 00859244007043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other