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	06/08/2026
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 multiple attempts were made to place the electrode on both the lateral and septal walls; these attempts resulted in either unacceptable measurements or inability to achieve proper anchoring.The final placement attempt on the lateral wall demonstrated out-of-range angles but acceptable threshold and anchoring views.After anchoring was initially confirmed, withdrawal and re-advancement of the delivery catheter revealed that the electrode had become unanchored, appearing lodged in the basal lateral wall beneath the mitral valve.Throughout the procedure and post-procedure assessment, right ventricular pacing data showed inconsistent tracking and intermittent capture, which was also confirmed during pacu evaluations.The patient was returned to the lab for an attempted snare retrieval of the electrode; however, this was unsuccessful.Following release, consistent tracking could not be achieved despite adherence to best-practice optimization protocols, and tracking level and threshold could not be determined.Persistent low signal strength was observed throughout the procedure and follow-up despite repositioning the antenna directly against the battery pocket in multiple orientations.Continued follow-up approximately 14 minutes post-procedure showed ongoing low signal strength and inconsistent tracking, with only occasional tracked beats observed and one potential bi-ventricular qrs measurement obtained.Additional follow-up information received on 06/17/2026 indicated the patient reported recovering well from the procedure but continued to experience shortness of breath with exertion.Consistent tracking could not be obtained in all three postures, and no change was noted on 12-lead ekg in lvoo at maximum output.Bi-ventricular pacing was noted at 1%.

• 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: 25693472
• Report Number: 3013596742-2026-00052
• Device Sequence Number: 9720695
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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: P260052
• 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: 06/08/2026
• Supplement Date Received by Manufacturer: 06/08/2026; 06/08/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 08/31/2026; 10/01/2026
• 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