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

Model Number	M301
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	08/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.G4: pma/510(k) # field on 3500a form is k193473, k210608 - reported here as pma # exceeded character limit for designated field.
Event or Problem Description
It was reported that a health care professional (hcp) identified a device malfunction.The insertable cardiac monitor (icm) will no longer transmit data, and the only corrective action is explant and reimplant.The hcp was advised to return the explanted device for analysis and informed that a letter of analysis can be requested if needed.The hcp plans to discuss next steps with the physician.No adverse patient effects were reported.This icm remains in service.Additional information received indicates that technical services identified an internal malfunction and recommended device replacement.The representative confirmed the change-out has already been completed, likely on the day of the initial call, and patient records can verify this.The original icm remains with the hospital and will be returned at their discretion.No adverse 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: 23674023
• Report Number: 2124215-2025-87634
• Device Sequence Number: 9761985
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(17)250130
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

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 Expiration Date: 01/30/2025
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 196430
• 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: 11/17/2025
• Initial Report FDA Received Date: 11/28/2025
• Date Device Manufactured: 08/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male