BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WISE CRT SYSTEM

    MDR report key: 23375846 · Received October 23, 2025

    Report

    Report Number
    3013596742-2025-00022
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 24, 2025
    Report Date
    December 8, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    PMA / PMN Number
    P240028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MODEL 4100 WISE TRANSMITTER (S/N (B)(6)) REMAINS IMPLANTED IN THE PATIENT, AS NOTED IN THE INITIAL MFR 3013596742-2025-00022. THE INVESTIGATION IS CURRENTLY ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED TO INCLUDE THE FINAL ANALYSIS AND CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED ON 24 SEPTEMBER 2025 REPORTING AN INSULATION BREAKDOWN ON THE TRANSMITTER CABLE OF A MODEL 4100 WISE CRT SYSTEM (TRANSMITTER SN (B)(6)) DURING BATTERY REPLACEMENT. IMAGES SUPPLIED WITH THE COMPLAINT CONFIRMED A LOCALIZED BREACH OF THE CABLE INSULATION NEAR THE BATTERY-SIDE STRAIN RELIEF. DESPITE THE DAMAGE, THE SYSTEM CONTINUED TO PROVIDE STABLE RVPD AND BIV PACING BEFORE AND AFTER BATTERY EXCHANGE. THE TRANSMITTER REMAINS IMPLANTED; THEREFORE, FULL FUNCTIONAL TESTING AND DEVICE-LEVEL ANALYSIS COULD NOT BE PERFORMED. REVIEW OF LATERAL X-RAYS SUGGESTS THE TRANSMITTER CABLE MAY NOT HAVE BEEN ROUTED ACCORDING TO RECOMMENDED GUIDELINES, RESULTING IN POTENTIAL KINKING NEAR THE STRAIN RELIEF. THIS MECHANICAL STRESS IS THE SUSPECTED CAUSE OF THE INSULATION FAILURE; HOWEVER, THE ROOT CAUSE CANNOT BE CONFIRMED WITHOUT DEVICE RETRIEVAL. MANUFACTURING AND LOT HISTORY RECORDS FOR THE TRANSMITTER AND ASSOCIATED SUBASSEMBLY SHOWED NO DISCREPANCIES, AND ALL INSPECTIONS MET SPECIFICATIONS. BASED ON AVAILABLE EVIDENCE, THE MOST PROBABLE CAUSE IS MECHANICAL STRAIN RELIEF FAILURE AT THE BATTERY JUNCTION, POTENTIALLY EXACERBATED BY SUBOPTIMAL CABLE ROUTING. INCREASED PATIENT FOLLOW-UP AT 3-MONTH INTERVALS AND INCLUSION OF THIS CASE IN POST-MARKET SURVEILLANCE TRENDING FOR STRAIN RELIEF-RELATED FAILURES ARE RECOMMENDED.

    Additional Manufacturer Narrative · 0

    THE MODEL 4100 WISE TRANSMITTER (S/N (B)(6)) REMAINS IMPLANTED IN THE PATIENT; THEREFORE, A PHYSICAL EVALUATION OF THE DEVICE IS NOT POSSIBLE AT THIS TIME. ALTERNATIVE SOURCES OF INFORMATION, INCLUDING PROGRAMMER LOGS, BATTERY PERFORMANCE CURVES, AND PHOTOGRAPHS, WILL BE UTILIZED TO SUPPORT THE ONGOING INVESTIGATION. 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 AS SUPPLEMENTAL REPORT IF ADDITIONAL INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE MODEL 3100 WISE BATTERY REPLACEMENT, AN INSULATION BREAKDOWN WAS IDENTIFIED ON THE TRANSMITTER CABLE CONNECTED TO MODEL 4100 TRANSMITTER T01362. DEPSITE THE BREACH, THE SYSTEM CONTINUED TO EXHIBIT STABLE WISE FUNCTION WITH CONSISTENT RIGHT VENTRICULAR PULSE DETECTION (RVPD) AND BIV PACING BOTH PRE AND POST BATTERY REPLACEMENT. A FOLLOW UP IS SCHEDULED IN 2 WEEKS FOR A WOUND AND DEVICE PERFORMANCE CHECK. NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223033 WISE CRT SYSTEM MODEL 4100 SEG EBR SYSTEMS, INC. MODEL 4100 20319-04

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male