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	06/25/2026
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.G4: pma/510(k) # field on 3500a form contains an additional code - k210608; reported here as it exceeded character limit for designated field.
Event or Problem Description
It was reported that monitoring was disabled due to a suspected insertable cardiac monitor (icm) device malfunction, and the patient was not monitored because of an unresolved issue with the icm, indicating that device replacement was initially considered necessary.Technical services (ts) review found that the latitude system briefly reported a bootloader operating state; however, subsequent icm device data showed normal operation with no device faults.Based on the available information, it was determined that the icm likely functioned correctly and that the issue was more likely related to a temporary communication problem between the icm and latitude monitoring system.No adverse patient effects were reported.This icm remains in service.

• 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 ; +1(651)582-6168
• MDR Report Key: 25774548
• Report Number: 2124215-2026-37036
• Device Sequence Number: 21240786
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(17)240719
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K193473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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: 07/19/2024
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 175521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 02/01/2023
• 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: 76 YR
• Patient Sex: Unknown