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

Model Number	M1000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The potential for untimed pacing stimulation during exposure to ultrasound, including echocardiographic imaging, is addressed in the pma-approved labeling.Specifically, the instructions for use (ifu; lbl-05300) include a precaution regarding exposure of patients to sources of ultrasound, noting that the wise system may be susceptible to untimed pacing stimulation when exposed to ultrasound energy, with the potential risk being highest within the first 30 days following implantation (reference section 5.4).Additionally, the ifu recommends using ecg monitoring, having a defibrillator available, and outlines actions to be taken in the event of untimed stimulation during any diagnostic ultrasound imaging.Furthermore, the alternative echo protocol (lbl-10003-a) is a supplemental resource available to healthcare providers when performing diagnostic ultrasound imaging and describes a reduced-power mechanical index (mi) titration approach to mitigate this risk.At this time, the cause of the event remains unknown.There is insufficient information available to establish a causal relationship between the device, the procedure, user factors, or other clinical conditions and the reported event.Device contribution cannot be excluded.An internal investigation is ongoing, and this report will be updated through supplemental submission as additional information becomes available and the investigation progresses.In the attached files, references to ultrasound-induced extra or untimed pacing stimulation are found on pages 3-4 of the alternative echo protocol (lbl-10003-a) and pages 6-7 and 9 of the common section ifu (lbl-05300 rev b), with the most detailed procedural guidance provided in section 5.4 (page 7) of the ifu.Ebr submits this report in accordance with fda regulations 21 cfr parts 4 and 803.Ebr has made reasonable efforts to obtain and provide all relevant information available as of the date of this report.This submission does not represent an admission or conclusion by the fda, ebr, or its employees that the device or its use caused or contributed to the reported event.Fields left blank indicate information that is unknown or unavailable at this time.Ebr will submit a supplemental report if additional relevant information becomes available.
Event or Problem Description
On (b)(6) 2026, a patient who had undergone a successful wise electrode implant procedure on (b)(6) 2026, experienced ventricular tachycardia (vt) that progressed to ventricular fibrillation (vf) during a routine transthoracic echocardiogram (tte) examination in the icu setting (1-day post-procedure).The patient was successfully treated by a previously implanted defibrillator, which delivered therapy and restored the patient to a paced rhythm.At the time of the event, the patient was undergoing tte and was being monitored with a 12-lead electrocardiogram (ecg).Reported ecg recordings demonstrated one to two premature ventricular contractions (pvcs) preceding the onset of vt, subsequently degenerating into vf.There was no observed period of sustained high-rate pacing preceding the event; rather, isolated pvcs appeared to trigger the arrhythmia.The wise electrode implant procedure had been completed without reported complications on the prior day, and the tte was reported to have been ordered and performed as part of routine clinical care per the treating physician.Ebr has made multiple attempts to obtain additional information regarding this event from the implanting physician, including both verbal (telephone) and written (email) requests.A final request for information was submitted via email on june 15, 2026.As of the date of this report, the requested information has not been provided.In a response dated june 9, 2026, the physician indicated that he had been instructed by the va leadership team not to share additional information at that time.

• 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: 25602221
• Report Number: 3013596742-2026-00053
• Device Sequence Number: 9972111
• Product Code: SEG
• UDI-Device Identifier: 00859244007043
• UDI-Public: 00859244007043
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M1000
• Device Lot Number: P260052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 06/04/2026; 06/04/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 07/30/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2026
• 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: Life Threatening; Other
• Patient Age: 80 YR
• Patient Sex: Male