MAUDE Adverse Event Report: EBR SYSTEMS, INC. WISE CRT SYSTEM; M4100

Model Number	M4100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	02/06/2026
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 iin the report.Any required fields that are unpopluated are blank because the information is currently unknown or unavailable.Ebr will submit a supplemental report if additional information becomes known.
Event or Problem Description
On (b)(6) 2026, the clinical site reported that a patient experienced abnormal heart sensations.No additional details regarding severity, duration, or device performance were provided at the time of initial notification.No adverse patient sequelae were reported.
Additional Manufacturer Narrative
The products remain implanted and will not be returned to the manufacturer for evaluation.Therefore, the investigation will be limited to a review of the device labeling (instructions for use), lot history records (lhr), and available clinical data.A supplemental report will be submitted if additional information becomes available.
Additional Manufacturer Narrative
The investigation remains ongoing.Additional information has been requested from the clinical team; however, no further details have been provided to date.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
Additional Manufacturer Narrative
The model 1000 electrode catheter (s/n (b)(6)), model 3100 battery (s/n (b)(6)), and model 4100 transmitter (s/n (b)(6)) remain implanted in the patient and were not returned to ebr systems for evaluation; therefore, visual inspection and functional performance testing could not be performed.Available complaint information was reviewed as part of the investigation.It was reported that the patient experienced abnormal heart sensations; however, no additional clinical details or device performance concerns were provided.A review of manufacturing documentation, including lot history records, sterilization records, and vendor test records for the associated devices, confirmed that all manufacturing, testing, and release requirements were met.The devices met all applicable acceptance criteria, and no manufacturing discrepancies or nonconformances were identified that could be associated with the reported event.Because the devices were not returned and no device malfunction or performance issue was identified based on the available information, the reported event could not be reproduced.Based on the available information, the investigation did not identify evidence that the wise crt system malfunctioned or that device performance contributed to the reported patient symptoms.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: M4100
• Manufacturer (Section D): EBR SYSTEMS, INC.; 480 oakmead parkway; sunnyvale CA 94085
• Manufacturer (Section G): EBR SYSTEMS, INC.; 680 oakmead parkway; sunnyvale CA 94085
• Manufacturer Contact: sonia finnegan ; 480 oakmead parkway; sunnyvale, CA 94085 ; 4087201906
• MDR Report Key: 24448548
• Report Number: 3013596742-2026-00009
• Device Sequence Number: 16064452
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• 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): 04/11/2026

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 Expiration Date: 08/04/2026
• Device Model Number: M4100
• Device Lot Number: P250203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/13/2026; 04/06/2026; 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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: Other
• Patient Sex: Unknown