MAUDE Adverse Event Report: EBR SYSTEMS, INC. WiSE CRT System; M4100

Model Number	M4100
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
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 " the patient's condition has recently worsened.He is retaining fluid and becomes very short of breath when walking".Additional information states "it is unknown if the physician believed that the patient's worsening condition or fluid retention was related to reduced biv pacing or wise performance.When the patient had trouble in previous positions minimal tracking was observed in all postures.There is no way to determine if there were any reports of posture-dependent loss of therapy at home without having an m5100 in the home to observe loc.The patient did not report symptoms that correlated with positional changes or loss of pacing.The reduced biv pacing was presumably related to the pleural effusion.The wise system was tracking at 71% upon initial interrogation.The physician did not recommend any intervention or system revision related to suspected wise performance.There were no concerns regarding transmitter position, acoustic window quality, or electrode location contributing to reduced therapy delivery".

• 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: taliah harris, bsn, rn ; 480 oakmead parkway; sunnyvale, CA 94085 ; +1(408)720-1906
• MDR Report Key: 25302142
• Report Number: 3013596742-2026-00043
• Device Sequence Number: 13091110
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2026
• Device Model Number: M4100
• Device Lot Number: P250166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: Not provided; 05/04/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/23/2026; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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
• Patient Sex: Unknown