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

Model Number	M4100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/10/2025
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 constituent 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 post subcutaneous implantation of the wise crt system pulse generator, the patient developed a hematoma.There is no evidence of active bleeding.This event was also resolved without any patient sequelae.
Additional Manufacturer Narrative
The battery (b)(6) and transmitter (b)(6) were not returned to ebr for analysis and remain implanted.A lot history record (lhr) review was conducted for both the battery (b)(6) and transmitter (b)(6).No nonconformances were identified during manufacturing that would explain the reported event.The reported patient symptom of hematoma is a known potential adverse event associated with the implantation procedure and is described in the instructions for use (ifu).
Additional Manufacturer Narrative
The model 4100 transmitter (s/n (b)(6)) remains implanted and was not returned to ebr systems for evaluation; therefore, visual inspection and functional testing could not be performed.A review of manufacturing and lot history records, including subassembly documentation, production test results, and sterilization records, confirmed that both devices met all acceptance criteria and were released in accordance with approved specifications.Hematoma formation is a known potential adverse event associated with implantable devices and is identified in the wise crt system instructions for use.Based on the available information, no evidence of device malfunction, performance issue, or manufacturing deficiency was identified that would have caused or contributed to the reported event.The investigation is complete, and no device-related root cause was identified.

• 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: 23930632
• Report Number: 3013596742-2025-00042
• Device Sequence Number: 9041510
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/12/2026

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: 12/19/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/28/2026; 02/12/2026
• 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: Other
• Patient Sex: Unknown