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

Model Number	M1000
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	05/05/2026
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.
Event or Problem Description
It was reported during a follow-up visit on (b)(6) 2026, the wise crt system demonstrated intermittent missed tracking events during in-clinic testing.The patient was unable to stand or lie flat; therefore, testing was performed in a modified sitting/supine position based on the patient's sleeping posture.The co-implanted abbott aveir dr device was programmed in aai/vvi mode, and per physician request, evaluation was also performed in vdd mode.During vdd mode testing, the wise crt system reportedly could not appropriately track or detect pacing activity.Device interrogation demonstrated stable system metrics including 2.96v battery voltage, 98% remaining capacity, normal battery curve, and 84% biv pacing with 57 rv pacing spikes below 140 bpm.Although stored data demonstrated 84% tracking, intermittent missed tracking events were observed during live testing.No patient sequalae were reported.

• Brand Name: WISE CRT SYSTEMS
• 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: 25144436
• Report Number: 3013596742-2026-00038
• Device Sequence Number: 9454071
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• 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 Model Number: M1000
• Device Lot Number: P250342
• 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: 05/05/2026
• 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: 11/20/2025
• 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