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

Model Number	M1000
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	03/23/2026
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.
Event or Problem Description
During a follow-up visit on (b)(6) 2026, interrogation of the wise crt system demonstrated appropriate rv pace detection; however, no electrode tracking was observed.Biv pacing since implant was reported as (b)(4).Multiple troubleshooting and programming assessments were performed for over one hour, including evaluation of system parameters and patient posture, but electrode tracking and biv pacing could not be achieved.Edge counts initially reported since implant were elevated; however, acute edge counts during the evaluation were near 1 and did not appear to affect rv pace detection.Device diagnostics showed normal battery status and appropriate system measurements.Chest x-rays were requested to further assess the positioning and status of the system components.No adverse patient sequelae were reported.
Additional Manufacturer Narrative
The investigation for this case remains ongoing and has not yet been completed.A supplemental report will be submitted once the investigation is finalized and results become available.

• 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: 24736891
• Report Number: 3013596742-2026-00018
• Device Sequence Number: 9242580
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/12/2026

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 Model Number: M1000
• Device Lot Number: P250295
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/14/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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