MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUX-DX II?; INSERTABLE CARDIAC MONITOR

Model Number	M302
Medical Device Problem Codes	Signal Artifact/Noise (1036); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinic being unable to establish communication with the insertable cardiac monitor (icm) using either in-clinic equipment or a bring-your-own-device (byod).Despite multiple attempts by technical service (ts) to initiate a patient-triggered interaction, the icm did not respond, and no haptic feedback was noted.The clinic also attempted to activate the icm using a magnet, but this was unsuccessful.Although the byod app showed active provisioning and normal functionality, and the mobile phone remained connected to the system, the presenting electrogram received consisted primarily of signal noise.Earlier presenting electrograms were the last to demonstrate identifiable cardiac activity.The icm did not migrate, and the user of the byod and app was unable to perform successful manual transmissions.Based on the repeated inability to wake or communicate with the system and the degraded presenting electrogram, ts recommended replacing the icm and returning it for analysis.The icm remains in service, with no reported adverse patient effects.The icm was explanted due to product performance issue and the icm was returned for analysis.
Additional Manufacturer Narrative
The supplemmental 01 was updated due the icm was explanted and returned for analysis.
Event or Problem Description
It was reported that the clinic being unable to establish communication with the insertable cardiac monitor (icm) using either in-clinic equipment or a bring-your-own-device (byod).Despite multiple attempts by technical service (ts) to initiate a patient-triggered interaction, the icm did not respond, and no haptic feedback was noted.The clinic also attempted to activate the icm using a magnet, but this was unsuccessful.Although the byod app showed active provisioning and normal functionality, and the mobile phone remained connected to the system, the presenting electrogram received consisted primarily of signal noise.Earlier presenting electrograms were the last to demonstrate identifiable cardiac activity.The icm did not migrate, and the user of the byod and app was unable to perform successful manual transmissions.Based on the repeated inability to wake or communicate with the system and the degraded presenting electrogram, ts recommended replacing the icm and returning it for analysis.The icm remains in service, with no reported adverse patient effects.

• Brand Name: LUX-DX II?
• Common Device Name: INSERTABLE CARDIAC MONITOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24482612
• Report Number: 2124215-2026-11314
• Device Sequence Number: 13421368
• Product Code: MXD
• UDI-Device Identifier: 00802526620713
• UDI-Public: (01)00802526620713(17)261107
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K231328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: Lay User/Patient
• Device Model Number: M302
• Device Catalogue Number: M302
• Device Lot Number: 116150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female