MAUDE Adverse Event Report: EBR SYSTEMS, INC. WISE CRT SYSTEM; MODEL 4100

Model Number	MODEL 4100
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Both the model 3100 battery and the model 4100 transmitter remain implanted in the patient.An additional supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
Additional information received on 23-september-2025 indicated that the transmitter was originally implanted in 2021 in the 3rd ics and corrected to the 4th ics one month later.During the (b)(6) 2025 reimplantation, explant confirmed the device was located in the 4th ics with fibrotic capsule and rib scarring consistent with chronic placement.The new transmitter was implanted in the same ics via tunneling with a penrose drain, and post-operative ekg confirmed stable biv pacing.The >2-year loss of biv pacing was attributable to the fsn and deferred replacement decision by the physician and patient.No abnormal device behavior was identified.The reimplantation was safe and successful.
Additional Manufacturer Narrative
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.
Event or Problem Description
The patient was seen for a device follow-up on (b)(6) 2025, after having a battery and transmitter replacement.During the visit, right ventricular (rv) pacing detection improved after reprogramming and syncing with the co-implant pulse width.However, the patient was not receiving the full benefit of biventricular (biv) pacing, which was estimated to be effective less than 40% of the time.Biv capture and tracking were noticeably affected by the patient's breathing, with better results during deep exhalation or when lying on the left side.Despite these issues, the patient had no symptoms, and no complications were reported.
Additional Manufacturer Narrative
Both the model 3100 battery and the model 4100 transmitter remain implanted in the patient.However the programmer logs were reviewed for analysis.Programmer log analysis confirmed that the newly implanted transmitter was placed in the same 4th intercostal space pocket as the previous transmitter, consistent with prior fibrotic scarring.Device parameters including acoustic distance, targeting angles, and noise profiles were within expected limits, and no device or software malfunction was identified.Findings indicate that partial lung encroachment into the acoustic window is the most probable cause of reduced pacing efficiency.This likely developed during the two-year therapy interruption, resulting in partial attenuation of ultrasound energy and higher capture thresholds.No malfunction of the wise crt system components was observed.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: MODEL 4100
• Manufacturer (Section D): EBR SYSTEMS, INC.; 480 oakmead parkway; sunnyvale CA 94085
• Manufacturer (Section G): EBR SYSTEMS, INC.; 480 oakmead parkway; sunnyvale CA 94085
• Manufacturer Contact: sonia finnegan ; 480 oakmead parkway; sunnyvale, CA 94085 ; 4087201906
• MDR Report Key: 22974281
• Report Number: 3013596742-2025-00019
• Device Sequence Number: 9549535
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2026
• Device Model Number: MODEL 4100
• Device Lot Number: P250166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/03/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown