MAUDE Adverse Event Report: EBR SYSTEMS, INC. WiSE CRT System; M1000

Model Number	M1000
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during the implant procedure, biventricular (biv) pacing was completely absent on the table following electrode deployment.Extensive intra-procedural troubleshooting was performed in accordance with best practice guidance, including evaluation for noise, adjustments to transmit level (tl) and pulse width, global search center optimization, sensor testing, patient repositioning, breath-hold maneuvers, and pocket manipulation.Despite these efforts, no tracking was achieved with any sensor except the vertical sensor, which demonstrated consistent tracking when enabled.Edge measurements remained stable at 1.000 throughout, with no indication of noise, and rv pace detection was consistent with no co-implant sensing issues.Acoustic window limitations were suspected, specifically potential air in the transmitter pocket.No additional programming changes were required post-operatively beyond restricting sensing to the vertical sensor, and consistent biv pacing was subsequently observed post-op.No adverse patient sequelae was reported.

• Brand Name: WiSE CRT System
• Common Device Name: M1000
• 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: taliah harris, bsn, rn ; 480 oakmead parkway; sunnyvale, CA 94085 ; +1(408)720-1906
• MDR Report Key: 24918629
• Report Number: 3013596742-2026-00022
• Device Sequence Number: 18747021
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/14/2026

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 Model Number: M1000
• Device Lot Number: P250295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/13/2026; 06/11/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown