BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WISE CRT SYSTEM

    MDR report key: 24974800 · Received April 23, 2026

    Report

    Report Number
    3013596742-2026-00027
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 20, 2026
    Manufacturer
    EBR SYSTEMS INC.
    Product Code
    SEG
    UDI-DI
    00859244007043
    PMA / PMN Number
    P240028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. 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 ON (B)(6) 2026, DURING A WISE CRT SYSTEM ELECTRODE IMPLANTATION PROCEDURE AT MUSC, A PROCEDURAL COMPLICATION INVOLVING PERICARDIAL EFFUSION REQUIRING SURGICAL INTERVENTION OCCURRED. THE PROCEDURE WAS STAGED, WITH THE BATTERY (MODEL 3100) AND TRANSMITTER (MODEL 4100) PREVIOUSLY IMPLANTED ON (B)(6) 2026. A CO-IMPLANT ABBOTT AVEIR VR LEADLESS PACEMAKER WAS PROGRAMMED IN VVI MODE. DURING ELECTRODE IMPLANTATION, MULTIPLE TARGET LOCATIONS WERE EVALUATED. AT THE SECOND LOCATION (MID LATERAL WALL), CONTRAST WAS INJECTED WITH EXCESSIVE FORCE THROUGH THE MANIFOLD, RESULTING IN VISIBLE MYOCARDIAL STAINING AND SUSPECTED TISSUE DISSECTION, CONFIRMED BY FLUOROSCOPY AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE SITE WAS ABANDONED. SUBSEQUENT POSITIONING ATTEMPTS WERE MADE. AT THE FOURTH LOCATION, ACCEPTABLE PRE-ANCHOR MEASUREMENTS WERE OBTAINED (DISTANCE 10.2 CM, ANGLE 30°, R-WAVE 5 MV, THRESHOLD 2.3V @ 0.5 MS, QLV 70 MS). DURING OR IMMEDIATELY FOLLOWING ANCHORING, PERICARDIAL EFFUSION WAS IDENTIFIED ON ICE. THE ELECTRODE WAS DEPLOYED AT APPROXIMATELY 11:34 AM WHILE THE CLINICAL TEAM PREPARED FOR INTERVENTION. FOLLOWING DEPLOYMENT, VENTRICULAR TACHYCARDIA OCCURRED, AND PACING/THRESHOLD ASSESSMENT COULD NOT BE COMPLETED. A PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR FURTHER MANAGEMENT. SURGICAL INTERVENTION INCLUDED, LEFT LATERAL THORACOTOMY AND EPICARDIAL PATCH REPAIR. POST-PROCEDURE, INTERMITTENT BIVENTRICULAR PACING WAS OBSERVED, THOUGH FULL ASSESSMENT WAS LIMITED DUE TO PATIENT INSTABILITY. THE SYSTEM REMAINED PROGRAMMED PER STANDARD SETTINGS. DEVICE STATUS INDICATED NORMAL BATTERY FUNCTION (3.18V, 100% CAPACITY) WITH NO EVIDENCE OF DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586080 WISE CRT SYSTEM M1000 SEG EBR SYSTEMS INC. M1000 P250342 00859244007043

    Patients

    Seq Age Sex Outcome Treatment
    1