BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WISE CRT SYSTEM

    MDR report key: 23375995 · Received October 23, 2025

    Report

    Report Number
    3013596742-2025-00025
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    October 2, 2025
    Report Date
    December 8, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    UDI-DI
    00859244007029
    PMA / PMN Number
    P240028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATTERY AND TRANSMITTER ARE EXPECTED TO BE RETURNED TO EBR FOR EXAMINATION. HOWEVER, DEVICE ANALYSIS IS NOT EXPECTED TO YIELD ANY FINDINGS RELATED TO THE REPORTED INFECTION, AS THE ISSUE IS BIOLOGICAL IN NATURE. ACCORDING TO THE WISE CRT SYSTEM IFU (LBL-05300, REV B), "ACCESS SITE AND POCKET COMPLICATIONS, INCLUDING INFECTION" ARE IDENTIFIED AS KNOWN POTENTIAL ADVERSE EVENTS.INFECTIONS ASSOCIATED WITH IMPLANTED MEDICAL DEVICES MAY RESULT FROM SEVERAL FACTORS, INCLUDING SUBOPTIMAL SURGICAL TECHNIQUE, INCOMPLETE POCKET CLOSURE, RETAINED SUTURES, COMPROMISED STERILITY BARRIERS, OR IMPAIRED WOUND HEALING. PREVENTIVE MEASURES INCLUDE ADHERENCE TO ASEPTIC TECHNIQUE, POST-IMPLANT WOUND CARE INSTRUCTIONS, AND USER TRAINING ON BATTERY AND TRANSMITTER HANDLING.NO DEVICE FUNCTIONAL ANOMALIES WERE REPORTED IN THE FIELD. BOTH THE BATTERY AND TRANSMITTER MET ALL PERFORMANCE SPECIFICATIONS AT THE TIME OF MANUFACTURING AND IMPLANTATION. A REVIEW OF THE LOT HISTORY RECORDS (LHR) REVEALED NO ANOMALIES. FOR TRANSMITTER LOT 072519-05, STERILITY, ENDOTOXIN, AND BIOLOGICAL INDICATOR TESTING MET ALL ACCEPTANCE CRITERIA. FOR BATTERY LOT 000169, (CIRTEC LOT QS377), NO NONCONFORMANCES WERE IDENTIFIED. BOTH DEVICES WERE MANUFACTURED AND STERILIZED IN COMPLIANCE WITH APPLICABLE STANDARDS.

    Additional Manufacturer Narrative · 0

    THE BATTERY (S/N (B)(6)) AND TRANSMITTER (S/N (B)(6)) INVOLVED IN THIS COMPLAINT WERE RETURNED TO EBR FOR ANALYSIS ON 03 DECEMBER AND SUBJECTED TO STANDARD VISUAL INSPECTION. THE SURFACES WERE CONSISTENT WITH NORMAL CLINICAL USE, AND NO VISUAL CONDITIONS WERE IDENTIFIED THAT COULD CONTRIBUTE TO, OR EXPLAIN, THE REPORTED POCKET INFECTION IN SUMMARY, ALTHOUGH THE PRODUCTS WERE RETURNED AND INSPECTED, VISUAL INSPECTION CANNOT CONFIRM OR PROVIDE EVIDENCE REGARDING THE REPORTED POCKET INFECTION EVENT, AS THE ISSUE IS BIOLOGICAL IN NATURE AND UNRELATED TO DEVICE PERFORMANCE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE'S MANUFACTURING AND STERILIZATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BATTERY POCKET PERFORATION WITH A POTENTIAL INFECTION RISK. THE PATIENT INITIALLY PRESENTED WITH MILD REDNESS AT THE INCISION SITE AND NO OVERT SIGNS OF INFECTION. OVER TIME, THE BATTERY ERODED THROUGH THE SKIN, RESULTING IN DEVICE EXPOSURE AND CREATING A POTENTIAL SITE FOR INFECTION. TO PREVENT INFECTION SPREAD, BOTH THE BATTERY AND TRANSMITTER WERE SUBSEQUENTLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503794 WISE CRT SYSTEM MODEL 3100 SEG EBR SYSTEMS, INC. M3100 000169 00859244007029

    Patients

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