MAUDE Adverse Event Report: EBR SYSTEMS INC. M4100; TRANSMITTER

Model Number	M4100
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Power Problem (3010)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
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 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.
Event or Problem Description
An elderly patient attended a follow-up visit on (b)(6) 2025 at (b)(6) hospital.During the visit, communication with the wise crt system could not be established despite adherence to best practice protocols.Ecgs confirmed right ventricular pacing only, even after pulse width adjustments.No adverse patient sequelae were reported.
Additional Manufacturer Narrative
At least 85% of the battery capacity is unaccounted for, indicating energy loss outside of normal operation of the device.Based on complaint analysis of devices with similar symptoms the most likely root cause is either dendritic growth across the battery plus kryoflex feedthrough or corrosive failure of the battery plus wire.
Additional Manufacturer Narrative
The wise crt model battery (b)(6) was implanted on (b)(6) 2024.On (b)(6) 2025, communication with the wise system could no longer be established.At the time of the communication loss, the battery was estimated to have approximately 85% of its capacity remaining.The model 3100 battery and the model 4100 transmitter remain implanted in the patient, and no planned explant dates have been communicated to ebr.As the model 4100 transmitter was not returned for analysis, the root cause of the communication failure could not be determined.However, the transmitter's serial number falls within the scope of capa: 20-001, which was initiated to address feedthrough failures.

• Brand Name: M4100
• Common Device Name: TRANSMITTER
• 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: 22196134
• Report Number: 3013596742-2025-00002
• Device Sequence Number: 18576694
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/06/2025

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: 02/06/2021
• Device Model Number: M4100
• Device Lot Number: 200130-04
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/12/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2020
• 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: Female