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

Model Number	M1000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported at a 6-month follow-up visit on (b)(6), 2026, that a patient implanted with the wise crt system experienced worsening heart failure symptoms.The patient had received an inappropriate shock from their subcutaneous implantable cardioverter defibrillator (s-icd) on (b)(6), 2026, and symptoms were reported to have begun following that event.Device interrogation demonstrated that the wise crt system was operating as intended.Battery voltage, remaining capacity, and depletion profile were within expected ranges.Biventricular (biv) tracking was 96%, and acoustic parameters (including edges per rv, distance, angle, and sensor performance) were within expected limits.Testing confirmed effective biv capture with observable transition on ekg from right ventricular pacing to biv pacing.An increase in pacing thresholds was observed compared to the two-week post-operative follow-up.The system was reprogrammed to higher output settings to maintain effective capture.The cause of the increased thresholds is unknown at this time.Additional clinical evaluation, including lab work, has been ordered.No adverse patient sequelae attributable to the wise crt system have been 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.Ebr will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
At the time of this report, the manufacturer's investigation remains ongoing.Additional information, including further evaluation results and any relevant findings related to the reported event, is being reviewed as part of the ongoing investigation.A supplemental report will be submitted if and when new, significant information becomes available upon completion of the investigation.

• 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 ; +1(408)720-1906
• MDR Report Key: 24961105
• Report Number: 3013596742-2026-00020
• Device Sequence Number: 20072214
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2026

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/19/2026; 06/16/2026; 09/18/2026
• 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