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

Model Number	M301
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Field g4 premarket/510k, from section g all manufacturers, contains both documents (b)(4) whose character limit prevented both entries from the field.
Event or Problem Description
It was reported that this insertable cardiac monitor (icm) depleted prematurely.The icm showed a decrease in battery voltage that appears to be faster than expected.It was recommended to return the device for analysis.The icm remains in service and no adverse patient effects were reported.

• 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23889517
• Report Number: 2124215-2025-93014
• Device Sequence Number: 21198372
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(17)241222
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/24/2025

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: 12/22/2024
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 191884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/24/2025
• Date Device Manufactured: 07/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Unknown