BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBR SYSTEMS, INC.

    MDR report key: 23410618 · Received October 29, 2025

    Report

    Report Number
    3013596742-2025-00024
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    October 3, 2025
    Report Date
    November 10, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    PMA / PMN Number
    P240028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INFORMATIONN 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 THE FDA, EBR OR ITS EMPLOYEE, 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 BATTERY WAS RETURNED TO EBR FOR EXAMINATION; HOWEVER, ANALYSIS OF THE RETURNED ITEM COULD NOT YIELD ANY RELEVANT INFORMATION RELATED TO THE REPORTED INFECTION. THE TRANSMITTER WAS NOT RETURNED FOR ANALYSIS. ACCORDING TO THE WISE CRT IFU (LBL-05300 REV B, SECTION 7), ACCESS-SITE AND POCKET COMPLICATIONS, INCLUDING INFECTION, ARE KNOWN POTENTIAL ADVERSE EVENTS. SUCH INFECTIONS ARE TYPICALLY PATIENT- OR PROCEDURE-SPECIFIC AND CAN RESULT FROM FACTORS SUCH AS SUBOPTIMAL WOUND CLOSURE, RETAINED SUTURES, OR IMPAIRED HEALING. NO FUNCTIONAL OR PERFORMANCE ISSUES WERE REPORTED, AND MANUFACTURING RECORDS CONFIRMED THAT BOTH THE BATTERY AND TRANSMITTER MET ALL SPECIFICATIONS PRIOR TO RELEASE. LOT HISTORY RECORD REVIEWS FOR BATTERY LOT 000275 AND TRANSMITTER LOT P250032 CONFIRMED THAT STERILITY, ENDOTOXIN, AND BIOLOGICAL INDICATOR TESTING MET ALL ACCEPTANCE CRITERIA. PARTER STERILIZATION REPORTS VERIFIED COMPLIANCE WITH TPI-10007, AND NO DEVIATIONS OR NONCONFORMANCES WERE IDENTIFIED. THE INVESTIGATION CONCLUDED THAT THE INFECTION WAS A PATIENT-SPECIFIC POST-OPERATIVE COMPLICATION AND NOT RELATED TO A DEVICE OR MANUFACTURING DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ELDERLY PATIENT UNDERWENT A BATTERY AND TRANSMITTER REPLACEMENT IN (B)(6) 2025. DURING POST-OPERATIVE WOUND HEALING, SIGNS OF INFECTION WERE OBSERVED AT THE TRANSMITTER SITE. MICROBIOLOGY CULTURE CONFIRMED STAPHYLOCOCCUS AUREUS INFECTION, AND THE PATIENT WAS STARTED ON IV ANTIBIOTICS. A PET SCAN ALSO REVEALED LOCALIZED INFLAMMATION. A MULTIDISCIPLINARY TEAM DETERMINED THAT DEVICE EXPLANT WAS THE MOST APPROPRIATE COURSE OF ACTION. DURING THE EXPLANT PROCEDURE PERFORMED ON (B)(6) 2025, THE CARDIOTHORACIC SURGEON OBSERVED A WELL-HEALED WOUND WITH NO VISIBLE SURFACE INFECTION. THE EXPLANTED TRANSMITTER WAS RETAINED BY THE HOSPITAL FOR FURTHER MICROBIOLOGICAL EVALUATION TO CONFIRM OR REFUTE INFECTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546429 EBR SYSTEMS, INC. M4100 SEG EBR SYSTEMS, INC. M4100 P250032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O