BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WISE CRT SYSTEM

    MDR report key: 22487696 · Received July 11, 2025

    Report

    Report Number
    3013596742-2025-00008
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 23, 2025
    Report Date
    August 7, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    UDI-DI
    00859244007005
    PMA / PMN Number
    P240028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE'S MANUFACTURING RECORDS WAS COMPLETED, INCLUDING LOT HISTORY; THERE WERE NO DEVIATIONS OR NONCONFORMITIES ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION, WHICH LIMITED THE ABILITY TO CONDUCT ANY PHYSICAL, FUNCTIONAL, AND/OR ROOT CAUSE ANALYSIS. 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.

    Additional Manufacturer Narrative · 0

    THE TRANSMITTER (S/N (B)(6)) REMAINS IMPLANTED INSIDE THE PATIENT. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD FOR THE TRANSMITTER LOT P250054 WAS PERFORMED AND IT IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF INFECTION WAS DEFINED IN THE RISK DOCUMENTATION, WHICH HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT.THE "KNOWN INHERENT RISK" CONCLUSION CODE WAS SELECTED BASED ON THE FIELD REPORT OF INFECTION OR INFECTION-RELATED CONDITIONS.INFECTION IS A KNOWN MEDICAL RISK WHEN THE SKIN BARRIER IS BREACHED. ANALYSIS OF THE RETURNED PRODUCT IS NOT ABLE TO PROVIDE RELEVANT INFORMATION FOR INFECTION-RELATED ALLEGATIONS.

    Description of Event or Problem · 0

    DURING THE FIRST FOLLOW UP AFTER IMPLANTATION, THE PATIENT REPORTED SYMPTOMS SUGGESTIVE OF AN INFECTION NEAR THE TRANSMITTER IMPLANTATION SITE. ON EXAMINATION, THE IMPLANTING PHYSICIAN OBSERVED FINDINGS CONSISTENT WITH A FUNGAL INFECTION AT THE WOUND SITE. AN ANTIFUNGAL CREAM WAS PRESCRIBED FOR TREATMENT. A REPORT SUMMARIZING THE FINDINGS AND TREATMENT PLAN WILL BE SENT TO THE PATIENT'S PRIMARY CARE PHYSICIAN AND CARDIOLOGIST TO SUPPORT COORDINATED CARE AND MONITOR THE PATIENT'S RESPONSE TO THERAPY. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    A FOLLOW-UP WAS CONDUCTED WITH THE EBR REPRESENTATIVE TO GATHER INFORMATION REGARDING THE PATIENT'S OUTCOME AND TO DETERMINE IF THE ISSUE HAS BEEN RESOLVED. ACCORDING TO THE EBR REPRESENTATIVE, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678075 WISE CRT SYSTEM M4100 SEG EBR SYSTEMS, INC. M4100 P250054 00859244007005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention