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

Model Number	M1000
Medical Device Problem Codes	Failure to Capture (1081); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the patient demonstrated consistent rv pace detection; however, no tracking or biv capture was observed.The patient came in with reduced tracking, and all steps outlined in the best-practice follow-up flowchart were performed in an attempt to optimize tracking, but tracking could not be achieved".Additional information received indicates the patient had 88% tracking at the prior 1 month visit , with no tracking issues noted at that time.Device thresholds were within expected ranges (1.5 supine, 5.0 sitting, 2.5 standing), with no programmer alerts, warnings, communication errors, or abnormal system messages identified during interrogation.Subsequent evaluation revealed inconsistent tracking across multiple positions and breathing maneuvers.R v pace detection remained stable (79 to 84 detections per minute) throughout interrogation.Rv retraining was attempted without lasting effect.Examination of the device pocket showed no evidence of rotation, hematoma, fluid accumulation, or migration.No imaging such as chest x-ray or fluoroscopy had been performed at the time of reporting.The physician did not determine a cause for the reduced tracking or decreased bi ventricular pacing.Clinical concern was raised for worsening heart failure potentially associated with reduced crt therapy.Compared to the march visit when the patient demonstrated stable tracking, narrow ekg, and improved symptoms, the patient presented with decompensation, including shortness of breath when supine.No medication changes were reported.The patient's spouse noted approximately 13 pound weight gain over 3 months, primarily in the abdominal region.No further information provided.
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.

• 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: 25340356
• Report Number: 3013596742-2026-00045
• Device Sequence Number: 10085187
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 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
• Device Model Number: M1000
• Device Lot Number: P250295
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: Not provided; 05/07/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/23/2026; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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