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	12/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Field g4 premarket/510k, from section g all manufacturers, contains both documents k193473 and k210608 whose character limit prevented both entries from the field.
Event or Problem Description
It was reported that the health care professional (hcp) called boston scientific technical services (ts) because this insertable cardiac monitor (icm) device had reached recommended replacement time (rrt) battery status earlier than expected and had not met the projected longevity.The hcp wondered if it could be related to the icm device settings.Ts mentioned settings were not suspected to be the cause of the reported battery condition and requested engineering to analyze the icm device data.In addition, ts discussed this patient was no longer being monitored due to the reported issue.Analysis of icm device data indicates the battery voltage dropped rapidly a few months before the rrt battery status occurred.The root cause is unknown; hence, the icm device should be returned for a detailed analysis.No adverse patient effects were reported.This icm device remains implanted at this time.

• 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: 23341480
• Report Number: 2124215-2025-74653
• Device Sequence Number: 7807965
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(17)250510
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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: 05/10/2025
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 198995
• 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: 09/30/2025
• Initial Report FDA Received Date: 10/20/2025
• Date Device Manufactured: 11/16/2023
• 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: 66 YR
• Patient Sex: Female