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

Model Number	MODEL 3100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pocket Erosion (2013); Unspecified Heart Problem (4454)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The battery (b)(6) was returned to ebr for analysis and received on 22 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
It was reported that a patient experienced wound dehiscence with battery erosion through the skin.A decision regarding battery replacement will be made following wound healing.No additional information has been received.
Additional Manufacturer Narrative
Both the battery (s/n (b)(6)) and the transmitter (t02419) were returned to ebr for evaluation.Returned product evaluation revealed no physical damage, contamination, or anomalies that could have contributed to the reported condition.Functional testing was not warranted as no performance issues were reported, and both devices met all manufacturing and release specifications.Lot history review (battery lot p240165; transmitter lot p250032) confirmed no manufacturing nonconformances, deviations, or sterility issues.The event is consistent with known procedural and patient-specific complications identified in the wise crt instructions for use, including wound healing issues and skin erosion overlying the implant site.The devices met specification with no evidence of malfunction or manufacturing defect.The event is attributed to patient and surgical factors, not a device failure.Device erosion and wound dehisence are known medical risks when the skin barrier is breached.Analysis of the returned product is not able to provide relevant information for skin erosion or wound dehiscence related allegations.
Additional Manufacturer Narrative
The initial mdr (3013596742-2025-00016) in section h11 incorrectly stated that battery (b)(6) was associated with this complaint.The correct devices associated with complaint (b)(4) are battery (b)(6) and transmitter (b)(6).These devices have not been returned to the manufacturer for analysis; however, follow-up efforts have been made to obtain product return status.A lot history record (lhr) review for both the battery (b)(6) and transmitter (b)(6) was performed.The review identified no process-related non-conformances, scrap, or rework during production that would explain the reported event.The reported patient symptoms of device erosion and wound dehiscence are recognized as potential adverse events or complications associated with the wise crt system, as described in the instructions for use (ifu).

• 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: 22986878
• Report Number: 3013596742-2025-00016
• Device Sequence Number: 13141400
• Product Code: SEG
• UDI-Device Identifier: 00859244007029
• UDI-Public: 00859244007029
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 10/23/2025

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: 01/18/2026
• Device Model Number: MODEL 3100
• Device Lot Number: P240165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/03/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female