MAUDE Adverse Event Report: EBR SYSTEMS, INC. WISE CRT SYSTEM; MODEL 4100

Model Number	MODEL 4100
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The battery (b)(6) and transmitter (b)(6) were returned to ebr for analysis and received on 27 august 2025.However, the investigation is in process.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 the fda, ebr or its employee, 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
The patient underwent a battery and transmitter replacement on (b)(6) 2025 due to the transmitter being affected by the feed through issue.Previously, in (b)(6) 2023, the patient had a battery replacement due to an irregular battery curve and premature depletion.During the most recent follow-up in (b)(6) 2024, connection to the wise crt system could not be established.No adverse patient sequelae were reported.
Additional Manufacturer Narrative
The patient's transmitter associated with this complaint was previously identified as being affected by kyroflex leakage, which caused excessive current drain.Although the battery was replaced at that time, the transmitter remained implanted, leading to premature depletion of the new battery.A full system replacement was delayed due to the patient's unrelated hip infection, which required resolution prior to surgical intervention.Battery voltage data was reviewed and showed accelerated depletion below the minimum threshold.Additionally, energy-based erc analysis revealed a 75% discrepancy, confirming abnormal energy consumption consistent with the known kyroflex-related issue.The excess current drain observed was directly attributable to the unresolved transmitter defect.Both the battery (t11035) and transmitter (t01393) associated with this complaint have since been returned for analysis; however, the investigation is still ongoing.A supplemental report will be provided once the product evaluation is complete.
Additional Manufacturer Narrative
Both the model 3100 battery (b)(6) and model 4100 transmitter (b)(6) were returned to ebr systems for analysis.Inspection confirmed yellow kryoflex polymer residue and corrosion near the connector interface, consistent with the known kryoflex leakage failure mode that causes conductive pathways and excess current drain.Review of historical device data showed that this transmitter had previously been identified as affected by kryoflex leakage but was not replaced at that time.The resulting elevated current consumption led to premature battery depletion and loss of system communication.Battery performance data demonstrated voltage decline below the minimum reference line and a 75% energy-based erc discrepancy at loss of communication on 26-aug-2025, confirming abnormal depletion consistent with kryoflex-induced current leakage.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: MODEL 4100
• 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: 22986872
• Report Number: 3013596742-2025-00017
• Device Sequence Number: 8972487
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• 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: 2020
• 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): 10/23/2025

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: 07/31/2020
• Device Model Number: MODEL 4100
• Device Lot Number: 072519-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/25/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown