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	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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.
Event or Problem Description
It was reported that an initial wise crt system implant procedure was performed on (b)(6) 2026 at university of (b)(6) hospital.During the procedure, difficult imaging conditions associated with a reprocessed ice catheter and suboptimal cine imaging were encountered.Carto mapping identified the lateral wall as the only suitable implant location due to non-existent septal activation.Following electrode release, intermittent electrode tracking and intermittent biventricular (biv) pacing were observed.Additional information received on 08-may-2026 indicated that inconsistent tracking persisted during a pre-discharge follow-up visit on (b)(6) 2026.Threshold testing demonstrated capture at tl 6.0 @ 2.0 ms in supine and sitting positions; however, the system remained programmed at maximum output settings of tl 6.0 @ pw 4.4 ms due to inconsistent tracking and elevated thresholds.Device interrogation showed normal battery status and battery curve, but projected rrt and eos dates were reduced due to sustained high-output requirements.Intermittent biv pacing persisted post-operatively, although qrs narrowing during biv pacing confirmed intermittent therapeutic capture.No adverse patient sequeale were reported.

• 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: 25143986
• Report Number: 3013596742-2026-00037
• Device Sequence Number: 21195724
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Model Number: M1000
• Device Lot Number: P260052
• 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: 06/03/2026; 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2026
• 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