BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WISE CRT SYSTEM

    MDR report key: 22986878 · Received September 5, 2025

    Report

    Report Number
    3013596742-2025-00016
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 21, 2025
    Report Date
    October 23, 2025
    Manufacturer
    EBR SYSTEMS, INC
    Product Code
    SEG
    UDI-DI
    00859244007029
    PMA / PMN Number
    P240028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATTERY (B)(6) WAS RETURNED TO EBR FOR ANALYSIS AND RECEIVED ON 22 AUGUST 2025. HOWEVER, THE INVESTIGATION IS IN PROCESS. 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 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

    BOTH THE BATTERY (S/N (B)(6)) AND THE TRANSMITTER (T02419) WERE RETURNED TO EBR FOR EVALUATION. RETURNED PRODUCT EVALUATION REVEALED NO PHYSICAL DAMAGE, CONTAMINATION, OR ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS NOT WARRANTED AS NO PERFORMANCE ISSUES WERE REPORTED, AND BOTH DEVICES MET ALL MANUFACTURING AND RELEASE SPECIFICATIONS. LOT HISTORY REVIEW (BATTERY LOT P240165; TRANSMITTER LOT P250032) CONFIRMED NO MANUFACTURING NONCONFORMANCES, DEVIATIONS, OR STERILITY ISSUES. THE EVENT IS CONSISTENT WITH KNOWN PROCEDURAL AND PATIENT-SPECIFIC COMPLICATIONS IDENTIFIED IN THE WISE CRT INSTRUCTIONS FOR USE, INCLUDING WOUND HEALING ISSUES AND SKIN EROSION OVERLYING THE IMPLANT SITE. THE DEVICES MET SPECIFICATION WITH NO EVIDENCE OF MALFUNCTION OR MANUFACTURING DEFECT. THE EVENT IS ATTRIBUTED TO PATIENT AND SURGICAL FACTORS, NOT A DEVICE FAILURE. DEVICE EROSION AND WOUND DEHISENCE ARE KNOWN MEDICAL RISKS WHEN THE SKIN BARRIER IS BREACHED. ANALYSIS OF THE RETURNED PRODUCT IS NOT ABLE TO PROVIDE RELEVANT INFORMATION FOR SKIN EROSION OR WOUND DEHISCENCE RELATED ALLEGATIONS.

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR (3013596742-2025-00016) IN SECTION H11 INCORRECTLY STATED THAT BATTERY (B)(6) WAS ASSOCIATED WITH THIS COMPLAINT. THE CORRECT DEVICES ASSOCIATED WITH COMPLAINT (B)(4) ARE BATTERY (B)(6) AND TRANSMITTER (B)(6). THESE DEVICES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, FOLLOW-UP EFFORTS HAVE BEEN MADE TO OBTAIN PRODUCT RETURN STATUS. A LOT HISTORY RECORD (LHR) REVIEW FOR BOTH THE BATTERY (B)(6) AND TRANSMITTER (B)(6) WAS PERFORMED. THE REVIEW IDENTIFIED NO PROCESS-RELATED NON-CONFORMANCES, SCRAP, OR REWORK DURING PRODUCTION THAT WOULD EXPLAIN THE REPORTED EVENT. THE REPORTED PATIENT SYMPTOMS OF DEVICE EROSION AND WOUND DEHISCENCE ARE RECOGNIZED AS POTENTIAL ADVERSE EVENTS OR COMPLICATIONS ASSOCIATED WITH THE WISE CRT SYSTEM, AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED WOUND DEHISCENCE WITH BATTERY EROSION THROUGH THE SKIN. A DECISION REGARDING BATTERY REPLACEMENT WILL BE MADE FOLLOWING WOUND HEALING. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495867 WISE CRT SYSTEM MODEL 3100 SEG EBR SYSTEMS, INC MODEL 3100 P240165 00859244007029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other