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

Model Number	M1000
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	05/01/2026
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.Ebr will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the procedure there was an inadvertent detachment of an electrode unrelated to anchoring or embolization.Additional information states that during the procedure, an electrode detached and was observed floating in the left ventricle (lv), despite having been confirmed securely attached to the catheter prior to reinsertion.No abnormalities were found in the electrode system, including the catheter, delivery sheath, insertion tool, or hemostatic valve, and no air bubbles were detected.The exact cause of the detachment is unknown, but it may be related to improper positioning of the insertion tool or valve, as well as kinking of the transeptal sheath, which occurred both above the transmitter and during retrieval.The physician acknowledged detaching the electrode while the balloon was not in the recommended position.The electrode was successfully retrieved in two attempts, taking approximately 10 minutes and 30 minutes respectively, with interventional radiology consulted for support.The patient was monitored in the hospital for two days, with follow-up checks showing stable electrode positioning, consistent tracking, and effective biv pacing.No hemodynamic changes, arrhythmias, or other adverse effects were observed, and the physician ultimately attributed the event primarily to the patient's anatomy.

• 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: 25220142
• Report Number: 3013596742-2026-00041
• Device Sequence Number: 9801564
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2026

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
• Date Returned to Manufacturer: 05/18/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/17/2026; 08/13/2026
• 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