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

Model Number	M4100
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Heart Problem (4454)
Date of Event	01/28/2026
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 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 unavailalbe.Ebr will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a patient in the wise-up registry study experienced significant left chest wall pain (8/10) beginning on the evening of the procedure and persisting overnight.Physical examination identified localized swelling and tenderness consistent with a hematoma, without active bleeding.Hemoglobin remained stable, with mild leukocytosis considered reactive to the recent procedure.Chest x-ray showed no pneumothorax or other acute complications.No additional information was provided.
Additional Manufacturer Narrative
The involved devices include model 3100 battery (s/n (b)(6)) and model 4100 transmitter (s/n (b)(6)).The battery and transmitter remain implanted and were not returned for evaluation; therefore, visual inspection and bench testing could not be performed.A review of device manufacturing and release records confirmed the devices met all specifications prior to distribution.No device malfunction or performance issue was identified.Hematoma is a known potential adverse event associated with surgical implantation procedures and is disclosed in the instructions for use.Based on the available information, the event is considered procedure-related.There is no evidence to suggest the wise crt system malfunctioned or contributed to the reported event.

• 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: 24254536
• Report Number: 3013596742-2026-00006
• Device Sequence Number: 8327170
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 02/18/2026

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 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: 01/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization
• Patient Sex: Unknown