MAUDE Adverse Event Report: EBR SYSTEMS, INC. WISE CRT SYSTEM; M4100

Model Number	M4100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	11/05/2025
Type of Reportable Event	Death
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
It was reported that the subject experienced acute hypoxemic respiratory failure (ahrf).Ebr is awaiting completion of the case report form (crf) from the clinical site to obtain additional details regarding this event.No further information is available at this time.
Additional Manufacturer Narrative
The model 3100 battery (s/n (b)(6)) and model 4100 transmitter (s/n (b)(6)) were not returned for evaluation; therefore, no visual inspection or functional testing was performed.The primary cause of death was documented as respiratory failure.The site determined that the patient's death was not related to the wise procedure, battery, transmitter, electrode, or system function.Manufacturing and lot history records confirmed that both devices met all acceptance criteria, with minor nonconformances previously reworked and found to have no impact on safety or performance.Based on the available information, no device-related root cause was identified, and the event is assessed as a non-device-related clinical outcome.
Event or Problem Description
Additional information received on 12/19/2025 indicated that the patient had passed away.According to the clinical site, the death was classified as non-cardiac, with the primary cause of death being respiratory failure.There was no relationship identified between the reported death and the procedure or the wise devices.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: M4100
• 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: 23846291
• Report Number: 3013596742-2025-00032
• Device Sequence Number: 9527320
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 01/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2026
• Device Model Number: M4100
• Device Lot Number: P250203
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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
• Outcome Attributed to Adverse Event: Death; Other
• Patient Sex: Unknown