MAUDE Adverse Event Report: EBR SYSTEMS, INC. WISE CRT SYSTEM; M1000

Model Number	M1000
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a 6-week follow-up visit on (b)(6) 2026, the wise crt system demonstrated consistent rv pace detection and consistent electrode tracking; however, no biventricular (biv) capture was observed on 12-lead ecg in supine or sitting positions despite maximum output programming at tl 6.0 @ 4.4 ms.The patient was unable to undergo standing positional testing due to blood pressure issues and a history of stroke with neurological distress.Device interrogation showed approximately 95% tracking with edges per rv of 1.057 and a mean electrode distance of 12.3 cm.Battery voltage was 2.87 v with reduced projected longevity attributed to sustained high-output therapy requirements.Threshold testing could not be completed because capture was not achieved in tested positions.The system remained programmed at maximum output settings in rv synchronous mode.No adverse patient sequelae were reported.
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.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: M1000
• 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: 25144924
• Report Number: 3013596742-2026-00039
• Device Sequence Number: 9351199
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 06/24/2026

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: 06/22/2026
• Device Model Number: M1000
• Device Lot Number: P250144
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/05/2026; 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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