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

Model Number	M1000
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	05/06/2026
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.Ebr will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that "during a follow-up visit increased wise capture thresholds necessitated reprogramming the device to higher output settings, resulting in a significant reduction in projected battery longevity".Additional information states that during the follow-up appointment it was confirmed that the patient's increased pacing thresholds were consistent across multiple checks and body positions.Despite a reported 99% biv tracking, ekg results showed no morphology changes, indicating that the issue was related to lv capture rather than tracking.Device evaluations found no evidence of electrode migration, transmitter movement, telemetry issues, or abnormal device behavior, with stable distance and angle measurements compared to prior visits.Battery performance was normal aside from the higher output required due to increased thresholds, and rv pacing detection was functioning correctly.The physician did not identify a clear cause but suspected suboptimal therapy delivery as a reason for the patient's lack of symptomatic improvement.As a result, the patient was programmed at threshold settings and scheduled for a follow-up in one month to reassess symptom improvement versus battery longevity.The patient's outcome was reported as "no adverse health effects".

• 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: 25301529
• Report Number: 3013596742-2026-00042
• Device Sequence Number: 13101838
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 08/25/2026

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: 08/11/2026
• Device Model Number: M1000
• Device Lot Number: P250214
• Was Device Available for Evaluation?: No
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: Not provided; 05/06/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/23/2026; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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