MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUX-Dx II?; Insertable Cardiac Monitor

Model Number	M302
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a field representative contacted technical services (ts) because neither the clinic mobile monitor (cmm) nor the tablet could connect to the insertable cardiac monitor (icm).Multiple troubleshooting steps were performed, including use of a magnet, cmm and tablet restarts, bluetooth reset attempts, network verification, and verification of mylux application settings and connectivity.The icm could be seen and felt, and no environmental factors that could have affected the icm were identified.All interrogation methods failed to establish communication with the icm.The issue remained unresolved, and ts indicated that the patient would likely require an icm replacement procedure, with the representative coordinating next steps with the physician.Additional information from the representative indicated that no formal action plans have been established at this time.Additional information indicates that this icm was explanted and replaced with a new icm device.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50223050
• Report Number: 2124215-2026-43158
• Device Sequence Number: 10436794
• Product Code: MXD
• UDI-Device Identifier: 00802526620713
• UDI-Public: (01)00802526620713(17)250718
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K231328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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 Expiration Date: 07/18/2025
• Device Model Number: M302
• Device Catalogue Number: M302
• Device Lot Number: 102581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 02/02/2024
• 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: 83 YR
• Patient Sex: Male