MAUDE Adverse Event Report: EBR SYSTEMS, INC. Wise CRT system; M4100

Model Number	M4100
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	05/04/2026
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.Ebr will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that " the patient's symptoms had not improved and a recent chest x-ray reportedly demonstrated significant rotation of the implanted model 4100 transmitter, described as pointing downward.The rotated transmitter position reportedly resulted in minimal tracking at maximum output settings.Troubleshooting and optimization were performed in accordance with the wise follow-up best practice flowchart.Adjustment of the gsc to the top and bottom of the search field resulted in intermittent tracking and intermittent biventricular (biv) pacing only at maximum output and pulse width settings and only while the patient was in a leaned-back sitting position".Additional information received states "it is unknown when the rotated transmitter was first identified, but there is x-ray to confirm.There was an attempt made to feel the transmitter pocket, but the patient had excessive tissue making it difficult to assess transmitter position.The leaned-back sitting position was the only position where the biv was achieved at max output.The physician talked to the patient and they both agreed to hold off on any further action and continue to assess the situation.The patient is still experiencing heart failure symptoms due to reduced biv pacing.Attempted to palpate the transmitter but was difficult to tell because the patient had lots of tissue.Attempted to palpate the transmitter but was difficult to tell because the patient had lots of tissue.Attempted to palpate the transmitter but was difficult to tell because the patient had lots of tissue".

• Brand Name: Wise CRT system
• Common Device Name: M4100
• 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: 25202486
• Report Number: 3013596742-2026-00036
• Device Sequence Number: 18361052
• Product Code: SEG
• UDI-Device Identifier: 00859244007005
• UDI-Public: 00859244007005
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2026

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 Expiration Date: 08/04/2026
• Device Model Number: M4100
• Device Lot Number: P250203
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/17/2026; 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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