MAUDE Adverse Event Report: EBR Sysems, Inc. WiSE CRT System; M3100

Model Number	M3100
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Heart Problem (4454)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury

• Brand Name: WiSE CRT System
• Common Device Name: M3100
• Manufacturer (Section D): EBR Sysems, 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 94085 ; +1(408)720-1906
• MDR Report Key: 50890691
• Report Number: 3013596742-2026-00060
• Device Sequence Number: 20340135
• Product Code: SEG
• UDI-Device Identifier: 00859244007029
• UDI-Public: 00859244007029
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P240028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M3100
• Device Lot Number: P260136
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2026
• 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: Hospitalization; Other
• Patient Sex: Unknown