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

Model Number	MODEL 4100
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Power Problem (3010)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an in-clinic follow-up visit, the battery curve appeared erratic and noisy.No intervention was performed at this time and the patient will continued to be monitored.No adverse sequelae was reported.
Additional Manufacturer Narrative
Ebr submits this report to comply with fda regulations 21 cfr parts 4 and 803.Ebr has provided as much relevant information asis 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.
Additional Manufacturer Narrative
The m3100 battery (s/n (b)(6)) and m4100 transmitter (s/n (b)(6)) remain implanted within the patient.Programmer logs and battery curve analysis revealed that between post-implantation days 5 and 50, the battery exhibited voltage swings of approximately 0.1v, which is not expected for a newly replaced battery.The voltage instability, characterized by these pronounced swing patterns, is consistent with excessive current draw.Based on historical patterns this is indicative of dendritic growth across the battery's positive terminal and the kryoflex feedthrough insulator.As the model 4100 transmitter was not returned for analysis, the root cause of the erratic battery curve could not be determined.However, the transmitter's serial number falls within the scope of capa 20-001, which was initiated to address feedthrough failures.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: BATTERY
• 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: 22333530
• Report Number: 3013596742-2025-00007
• Device Sequence Number: 15718383
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 07/25/2025

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 Expiration Date: 10/30/2019
• Device Model Number: MODEL 4100
• Device Lot Number: 102318-04
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MODEL 4100 PULSE GENERATOR: (B)(6)
• Patient Sex: Male
• Patient Race: White