MAUDE Adverse Event Report: EBR SYSTEMS, INC. WISE CRT SYSTEM; M3100

Model Number	M3100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
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
It was reported during a follow-up visit on (b)(6) 2026 that the patient developed a hematoma at the device pocket site and experienced soreness at the incision site.No additional intervention, device malfunction, or adverse clinical sequelae were reported at the time of follow-up.
Additional Manufacturer Narrative
At this time, the investigation has not identified a definitive root cause or confirmed device malfunction related to manufacturing or release activities.The manufacturer continues to evaluate all available information, including complaint history, procedural details, and any additional data received through follow-up activities.
Event or Problem Description
Additional information received on may 19, 2026, provided further details regarding the reported hematoma and patient symptoms.It was reported that the patient was evaluated in the office on (b)(6) 2026, for a hematoma located near the device pocket, described as moderate in size.It is unknown whether the hematoma was present immediately following the procedure or developed subsequently.Information regarding resolution status, need for medical or surgical intervention, use of anticoagulant or antiplatelet medications, and the presence of infection, skin breakdown, active bleeding, or swelling was not available.The patient reported discomfort associated with the hematoma; however, severity was not specified.Additionally, soreness was reported at the transmitter incision site and was described as mild to moderate.The soreness did not impact the patient's ability to perform daily activities.It is unknown whether the soreness is improving, stable, or worsening, and no information was provided regarding any recommended or prescribed treatment.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: M3100
• 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: 25118828
• Report Number: 3013596742-2026-00033
• Device Sequence Number: 10279943
• Product Code: SEG
• UDI-Device Identifier: 00859244007029
• UDI-Public: 00859244007029
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/23/2026

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 Model Number: M3100
• Device Lot Number: P250336
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/02/2026; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2025
• 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: Other
• Patient Sex: Unknown