MAUDE Adverse Event Report: EBR SYSTEMS, INC WISE CRT SYSTEM; M2000

Model Number	M2000
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, it was reported that during implantation, the electrode catheter did not detach using the standard handle mechanism and required manual detachment.Per the instructions for use (ifu), detachment confirmation and troubleshooting steps were performed.The prior egm signal showed no discontinuity.The blue safety interlock and orange detach button advanced fully; however, no audible click was heard, the orange circular boss did not fully return proximally, and the indicator window remained green.No electrical disturbance was observed on the pacing system analyzer.The delivery sheath was inspected and no kinks were identified.Manual detachment was performed in accordance with the ifu using a standard pacing hex wrench to advance the orange circular boss proximally, after which the electrode was successfully released.The procedure was prolonged by approximately 5-10 minutes.There were no adverse clinical consequences, including no pericardial effusion or embolization.Final pacing threshold was 1.0 v @ 0.5 ms with stable electrode position at case completion.The device was discarded by the hospital and is not available for analysis.No patient injury was reported.
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 the fda, ebr, or its employee, 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.
Additional Manufacturer Narrative
A correction is being made to section d2 of manufacturer report 3013596742-2026-00010 because the common device name was documented incorrectly.The device was originally listed as m1000; however, the correct common device name is m2000.The investigation is ongoing and has not yet been completed.A supplemental report will be submitted once the investigation has been completed and additional information becomes available.
Additional Manufacturer Narrative
The investigation remains ongoing and has not yet been completed.The electrode catheter will not be returned to ebr for analysis.It was reported that the catheter was discarded with procedural waste following the procedure.An attempt was made to recover the device; however, the attempt was unsuccessful.As the device is not available for return, device evaluation and functional testing cannot be performed.The investigation will therefore be limited to a review of available clinical information, device labeling (instructions for use), and manufacturing documentation, including the lot history record (lhr).A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
Event or Problem Description
It was reported that at the 1-month follow-up on (b)(6) 2026, the wise crt system demonstrated normal device performance.Battery voltage was 2.94 v with 96% remaining capacity and a normal battery curve.The system maintained stable rv pacing detection (edges ~1.007) with a mean acoustic distance of 7.8 cm and biv pacing of 97%.Programming was optimized by changing the targeting mode to reduced global search and disabling the vertical and front-back sensors.No device malfunctions or performance concerns were identified.
Additional Manufacturer Narrative
As part of the ongoing investigation, a comprehensive manufacturing review was performed, including lot history record (lhr) evaluation for the model 1000 electrode catheter (s/n (b)(6) and model 2000 delivery sheath (s/n (b)(6), along with all associated subassemblies.The review included assessment of manufacturing, inspection, sterilization, and lot release records, as well as evaluation of applicable nonconformances (ncrs) and deviations to verify appropriate disposition, traceability, and containment.All required in-process and final acceptance testing, including functional and performance verification, were completed in accordance with approved procedures and met established acceptance criteria.No discrepancies or conditions were identified within the manufacturing records that would suggest a manufacturing or quality-related contribution to the reported event.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

• Brand Name: WISE CRT SYSTEM
• Common Device Name: M2000
• 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 ; 4087201906
• MDR Report Key: 24476946
• Report Number: 3013596742-2026-00010
• Device Sequence Number: 10230173
• Product Code: SEG
• UDI-Device Identifier: 00859244007067
• UDI-Public: 00859244007067
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/15/2026

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: 09/10/2026
• Device Model Number: M2000
• Device Lot Number: P250249
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/13/2026; 04/06/2026; 05/03/2026; 05/21/2026; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• 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: Male