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

Model Number	MODEL 4100
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
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 battery fluctuations began around day 1296 post implant with an approximate date of (b)(6) 2025.The 100mv variation over the past 180 days is consistent with the failure pattern seen in kryoflex-related issues.The voltage instability, characterized by large voltage swings, is consistent with excessive current draw.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 22-007, which was initiated to address feedthrough failures.
Event or Problem Description
During a routine 4-year follow-up at (b)(6), fluctuations in battery voltage were observed on the battery performance curve of the patient's wise crt (cardiac resynchronization therapy) system.To date, there have been no reported adverse clinical outcomes or sequelae attributed to the device or the observed battery voltage fluctuations.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: TRANSMITTER
• 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
• MDR Report Key: 22745622
• Report Number: 3013596742-2025-00010
• Device Sequence Number: 4526677
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• 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
• 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
• Report Date (Section B): 08/07/2025

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: 04/14/2023
• Device Model Number: MODEL 4100
• Device Lot Number: 210331-02
• 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: 07/10/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown