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

Model Number	M301
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device has 2 premarket approvals and due to spacing limitations on field g4 they are k193473 and k210608.Patient initial reporter email not available.Email not given when initial requested on gmdt paperwork, patient decided not to give email to bsc.
Event or Problem Description
It was reported that the new patient mobile monitor (pmm) was received by the patient, and pairing was released again.The magnet attachment process was walked through, and setup was attempted but remained incomplete, resulting in disabled monitoring due possible device issue.The patient received education on the insertable cardiac monitor battery life and was referred to the clinic for further evaluation.The icm remains in service, and no adverse patient effects were reported.Additional information requested about the battery life, and the case was referred to the clinic for further evaluation.However, the information could not be provided due to unavailability from the customer/account.

• Brand Name: LUX-DX? INSERTABLE CARDIAC MONITOR
• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24381413
• Report Number: 2124215-2026-09181
• Device Sequence Number: 13308268
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(17)230623
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: Lay User/Patient
• Device Expiration Date: 06/23/2023
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 145385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 02/23/2022
• 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 Age: 86 YR
• Patient Sex: Unknown