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

Model Number	M3100
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	09/30/2025
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 asmuch 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 during the (b)(6) 2025 optimization session, no tracking to the electrode was observed despite an 85% biv pacing percentage.No tracking was achieved besides a brief period of tracking and biv capture about 20 beats which could not be maintained or replicated for the remainder of the follow-up.The patient was later found to have a large hematoma around the battery pocket and underwent a pleural effusion with greater than 2l of fluid removed from the left pleural cavity unrelated to the wise procedure or device.After a two-week recovery, tracking and biv capture were restored at the (b)(6) 2025 follow-up, with consistent performance confirmed during optimization.No further information was provided.
Additional Manufacturer Narrative
A patient developed a large device-pocket hematoma following a (b)(6) 2025 optimization session involving the wise crt system (model 3100 battery, s/n (b)(6); model 4100 transmitter, s/n (b)(6)).During the session, no tracking to the electrode was observed despite 85% biv pacing; only a brief period of tracking and capture (~20 beats) occurred.The patient later required drainage of >2 l from a left-sided pleural effusion.At follow-up on 16-oct-2025, tracking and biv capture were restored and device performance was stable.Devices remain implanted, and no visual inspection was possible.Review of available performance data revealed no device anomalies.Hematoma is a known potential adverse event listed in the system ifu.A lot history record review for both devices showed all manufacturing, in-process, and final inspection data met specifications, with no nonconformances identified.No device malfunction or manufacturing defect was found.The hematoma is most likely attributable to patient-specific or procedural factors rather than a device-related cause.

• Brand Name: WISE CRT SYSTEMS, INC.
• 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: 23527856
• Report Number: 3013596742-2025-00026
• Device Sequence Number: 21338733
• Product Code: SEG
• UDI-Device Identifier: 00859244007029
• UDI-Public: 00859244007029
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/09/2025

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: 02/17/2026
• Device Model Number: M3100
• Device Lot Number: P250167
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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: Required Intervention
• Patient Sex: Unknown