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

Model Number	M1000
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an electrode was implanted at a basal septal right ventricular location.Pre-anchor measurements were acceptable, the electrode was successfully anchored, post-anchor threshold improved to 0.8 v @ 0.5 ms, anchoring was confirmed in two fluoroscopic views, and both detachment indicators were observed prior to release.Immediately following release, the electrode became dislodged from the implant site.Review of the procedure indicated the dislodgement may have been associated with interaction between the delivery sheath and electrode during the release process, potentially due to significant torque within the delivery system resulting from maximum sheath deflection and possible incomplete de-sheathing of the electrode prior to withdrawal of the delivery catheter and sheath.The dislodged electrode was successfully retrieved using a snare without reported patient injury attributable to the dislodgement event.Please see associated mdr report # 3013596742-2026-00057.
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: sonia finnegan ; 480 oakmead parkway; sunnyvale, CA 94085 ; +1(408)720-1906
• MDR Report Key: 25820087
• Report Number: 3013596742-2026-00056
• Device Sequence Number: 10734146
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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
• Report Date (Section B): 09/11/2026

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?: Yes
• 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: 06/18/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 09/11/2026
• 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