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	06/04/2026
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 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 electrode tracking was occasionally intermittent and could not be maintained in any location.During subsequent evaluation, the transmitter was identified as flipped.The initial implant was performed on (b)(6) 2026, and was technically challenging due to tissue depth and patient body habitus (patient weight approximately 450 lbs).No electrode tracking issues were noted during this initial procedure.A repeat electrode implant was performed on (b)(6) 2026, at which time the flipped transmitter was identified.The transmitter pocket and placement were not revised during this procedure; therefore, suture-related issues could not be assessed.Per physician discussion, potential device manipulation by the patient was considered.The patient reported that at an unspecified date, he bent over and felt a "pop." a transmitter revision procedure is scheduled for (b)(6) 2026.

• 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 97085
• Manufacturer Contact: taliah harris, bsn, rn ; 480 oak\mead parkway; sunnyvale, CA 97085 ; +1(408)720-1906
• MDR Report Key: 25669717
• Report Number: 3013596742-2026-00050
• Device Sequence Number: 21445771
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

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
• Device Model Number: M4100
• Device Lot Number: P260026
• 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: 06/04/2026
• Supplement Date Received by Manufacturer: 06/04/2026; 06/04/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 08/25/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2026
• 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