MAUDE Adverse Event Report: EBR SYSTEMS, INC WISE CRT SYSTEM; M3100

Model Number	M3100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/24/2026
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 on (b)(6) 2026 that during a post-implant follow-up evaluation, the patient stated that she developed a hematoma with fluid accumulation at the battery incision site following the procedure.The clinic nurse examined the site and confirmed it was soft with no signs of infection, and the clinical team elected to monitor the area while allowing the fluid to dissipate naturally.No diagnostic testing or medication changes were reported, and there was no evidence of infection at either incision site or blood loss.The area had reportedly shifted toward the patient's back and was approximately the size of a softball.The ebr representative reported that the wise crt system was functioning as intended; however, elevated capture thresholds were observed compared to implant values.The patient is scheduled for a follow-up evaluation in may to reassess system performance.It was noted that thresholds may decrease once the post-operative fluid resolves, which may improve projected battery longevity.No additional patient complications were reported.
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.The device remains implanted and is not expected to be explanted; therefore, device testing cannot be performed at this time.Available clinical information and device performance data are being reviewed to further assess the event.A supplemental report will be submitted if additional relevant information becomes available.
Additional Manufacturer Narrative
The manufacturer's investigation remains ongoing; however, a device performance evaluation was performed based on available follow-up data.Programmer interrogation data from the most recent follow-up on 24-feb-2026 indicate that the implanted model 3100 battery and model 4100 transmitter remained operational and continued to communicate with the programmer.The device remained programmed in synch mode at the conclusion of the follow-up.No resets were reported, and battery status remained stable, with a recorded battery voltage of 2.94 v and estimated remaining capacity of 97%.Available performance data demonstrate continued therapy delivery, with biv pacing reported at 92.2%.Capture was confirmed across multiple body positions, including supine, sitting, and standing, with recorded thresholds of 6.0/1.70, 6.0/1.30, and 6.0/1.40, respectively.A capture threshold of 6.0/3.00 was also documented at this follow-up.Based on the available follow-up information, there is no evidence of loss of device function, loss of communication, or interruption of therapy delivery.The reported event of a post-implant hematoma at the battery incision site does not, based on the available device data, indicate a malfunction of the implanted battery or transmitter.A supplemental report will be submitted if additional relevant information becomes available.
Additional Manufacturer Narrative
The reported event involved development of a post-operative hematoma/fluid accumulation at the model 3100 battery incision site following implantation of the wise crt system.During a baseline/post-operative optimization follow-up on (b)(6) 2026, elevated pacing thresholds were also observed across multiple patient positions.The hematoma was described as soft, with no reported signs of infection, drainage, or blood loss.No surgical intervention, drainage procedure, or medication changes were reportedly required, and the patient remained under clinical monitoring.Review of available programmer interrogation and follow-up data demonstrated that the implanted model 3100 battery and model 4100 transmitter remained operational and continued to function as intended.The system remained rv synchronous with 92% biv tracking, normal battery curve behavior, and continued therapy delivery.Effective capture was maintained following programming adjustments despite elevated pacing thresholds.No resets, communication failures, loss of synchronization, or interruption of therapy delivery were reported.A manufacturing review, including review of lot history records, sterilization records, x-ray inspections, and vendor testing records for the associated battery and transmitter lots, was completed.All reviewed manufacturing documentation met applicable acceptance criteria and specifications.No manufacturing discrepancies or product nonconformances were identified that could be associated with the reported event.Investigation determined that hematoma formation is a known potential adverse event associated with implantable device procedures and is identified within the wise crt system instructions for use (lbl-05300 rev b).Available information did not identify evidence of device malfunction, manufacturing deficiency, migration, or mechanical failure contributing to the reported event.The elevated pacing thresholds observed during follow-up may have been influenced by the post-operative fluid accumulation surrounding the battery pocket site.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: M3100
• 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 ; 4087201906
• MDR Report Key: 24586090
• Report Number: 3013596742-2026-00013
• Device Sequence Number: 12193753
• Product Code: SEG
• 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
• 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): 05/20/2026

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: 02/17/2026
• Device Model Number: M3100
• Device Lot Number: P250167
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/02/2026; 04/27/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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: Hospitalization
• Patient Sex: Unknown