MAUDE Adverse Event Report: EBR SYSTEMS, INC. WiSE CRT System; M1000

Model Number	M1000
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	06/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following re-establishment of retroaortic access, the physician elected to return to the original basal septal target location.According to the procedure report, ebr personnel advised that the target location required extreme delivery sheath deflection and recommended selecting an alternative location requiring less deflection.The physician elected to proceed with the original target location.During navigation of the delivery system, progressive hypotension was noted by anesthesia.Echocardiography reportedly demonstrated no evidence of pericardial effusion.Ebr personnel recommended removal of sheath deflection to reduce potential pressure on surrounding structures; however, the procedure continued.The patient's blood pressure continued to decline, and ventricular tachycardia was subsequently observed, requiring three external defibrillation shocks.Sinus rhythm was restored, the procedure was aborted, and the patient was transferred to the icu for monitoring.Per site report, the patient stabilized shortly thereafter.Please see associated mdr# 3013596742-2026-.
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.

• 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: taliah harris, bsn, rn ; 480 oakmead parkway; sunnyvale, CA 94085 ; +1(408)720-1906
• MDR Report Key: 25820092
• Report Number: 3013596742-2026-00057
• Device Sequence Number: 10734150
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 09/11/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M1000
• Device Lot Number: P260052
• Was Device Available for Evaluation?: Yes
• 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: 06/18/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Other
• Patient Sex: Unknown