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	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient experienced a persistent connection issue and was unable to establish communication with the insertable cardiac monitor (icm).The patient attempted several troubleshooting steps, including turning off wi-fi, performing patient initiated interrogations (pii), forgetting and re-adding the device connection, and reinstalling the mylux application.Despite these actions and ensuring all permissions were enabled, the icm still did not pair with the patient's phone.The issue remained unresolved, and the patient was instructed to retry later or contact the clinic.Additional setup attempts using the patient's personal phone and a clinic mobile monitor (cmm) were also unsuccessful.Healthcare professionals tried different magnets and confirmed the implant could be felt, but pairing continued to fail.It was recommended to verify that the cmm in use was active and, if possible, to attempt pairing with a patient mobile monitor (pmm).The representative continued to support the clinic, and it was later confirmed that the icm was explanted due to the device performance issue.A new icm was implanted in the patient.No additional adverse patient effects were reported.

• 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: 24507069
• Report Number: 2124215-2026-12010
• Device Sequence Number: 10486262
• Product Code: MXD
• UDI-Device Identifier: 00802526620713
• UDI-Public: (01)00802526620713(17)270507
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K231328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: 122405
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/04/2026
• Date Device Manufactured: 11/18/2025
• 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: 68 YR
• Patient Sex: Female