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

Model Number	M1000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
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 on (b)(6) 2026, during a wise crt system electrode implantation procedure at musc, a procedural complication involving pericardial effusion requiring surgical intervention occurred.The procedure was staged, with the battery (model 3100) and transmitter (model 4100) previously implanted on (b)(6) 2026.A co-implant abbott aveir vr leadless pacemaker was programmed in vvi mode.During electrode implantation, multiple target locations were evaluated.At the second location (mid lateral wall), contrast was injected with excessive force through the manifold, resulting in visible myocardial staining and suspected tissue dissection, confirmed by fluoroscopy and intracardiac echocardiography (ice).The site was abandoned.Subsequent positioning attempts were made.At the fourth location, acceptable pre-anchor measurements were obtained (distance 10.2 cm, angle 30°, r-wave 5 mv, threshold 2.3v @ 0.5 ms, qlv 70 ms).During or immediately following anchoring, pericardial effusion was identified on ice.The electrode was deployed at approximately 11:34 am while the clinical team prepared for intervention.Following deployment, ventricular tachycardia occurred, and pacing/threshold assessment could not be completed.A pericardiocentesis was performed, and the patient was transferred to the operating room for further management.Surgical intervention included, left lateral thoracotomy and epicardial patch repair.Post-procedure, intermittent biventricular pacing was observed, though full assessment was limited due to patient instability.The system remained programmed per standard settings.Device status indicated normal battery function (3.18v, 100% capacity) with no evidence of device malfunction.No further information was provided.

• 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: 24974800
• Report Number: 3013596742-2026-00027
• Device Sequence Number: 17372339
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M1000
• Device Lot Number: P250342
• Was Device Available for Evaluation?: No
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/20/2026; 06/17/2026; 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown