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

Model Number	M302
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that setup using a patient personal phone and patient mobile monitor (pmm) failed in the clinic.Technical services recommended to retry pmm setup after the pairing with the patient personal phone was released, and the representative assisted the patient with the setup process.During a later review, the representative successfully connected to the insertable cardiac monitor (icm) using clinic assist, where a red screen alert indicated that monitoring had been disabled due to an icm malfunction.No adverse patient effects were reported.This icm remains in service.

• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25741933
• Report Number: 2124215-2026-36489
• Device Sequence Number: 10483639
• Product Code: MXD
• UDI-Device Identifier: 00802526620713
• UDI-Public: (01)00802526620713(17)261106
• 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: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2026

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: 116078
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 08/03/2026; 08/11/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/07/2026; 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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: 73 YR
• Patient Sex: Female