MAUDE Adverse Event Report: EBR SYSTEMS, INC. WISE CRT SYSTEM; MODEL 3100

Model Number	M3100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device's manufacturing and sterilization records was completed, including lot history; there were no deviations or nonconformities associated with the reported event.The device was not returned for evaluation, which limited the ability to conduct any physical, functional, and/or root cause analysis.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 the patient experienced a battery pocket perforation with a potential infection risk.The patient initially presented with mild redness at the incision site and no overt signs of infection.Over time, the battery eroded through the skin, resulting in device exposure and creating a potential site for infection.To prevent infection spread, both the battery and transmitter were subsequently removed.
Additional Manufacturer Narrative
The battery and transmitter are expected to be returned to ebr for examination.However, device analysis is not expected to yield any findings related to the reported infection, as the issue is biological in nature.According to the wise crt system ifu (lbl-05300, rev b), "access site and pocket complications, including infection" are identified as known potential adverse events.Infections associated with implanted medical devices may result from several factors, including suboptimal surgical technique, incomplete pocket closure, retained sutures, compromised sterility barriers, or impaired wound healing.Preventive measures include adherence to aseptic technique, post-implant wound care instructions, and user training on battery and transmitter handling.No device functional anomalies were reported in the field.Both the battery and transmitter met all performance specifications at the time of manufacturing and implantation.A review of the lot history records (lhr) revealed no anomalies.For transmitter lot 072519-05, sterility, endotoxin, and biological indicator testing met all acceptance criteria.For battery lot 000169, (cirtec lot qs377), no nonconformances were identified.Both devices were manufactured and sterilized in compliance with applicable standards.
Additional Manufacturer Narrative
The battery (s/n (b)(6)) and transmitter (s/n (b)(6)) involved in this complaint were returned to ebr for analysis on 03 december and subjected to standard visual inspection.The surfaces were consistent with normal clinical use, and no visual conditions were identified that could contribute to, or explain, the reported pocket infection in summary, although the products were returned and inspected, visual inspection cannot confirm or provide evidence regarding the reported pocket infection event, as the issue is biological in nature and unrelated to device performance.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: MODEL 3100
• 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: 23375995
• Report Number: 3013596742-2025-00025
• Device Sequence Number: 12961191
• Product Code: SEG
• UDI-Device Identifier: 00859244007029
• UDI-Public: 00859244007029
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/08/2025

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: 04/13/2025
• Device Model Number: M3100
• Device Lot Number: 000169
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/10/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Other
• Patient Sex: Unknown