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

Model Number	M302
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	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This insertable cardiac monitor (icm) device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Neither visual examination nor x-ray examination of the device identified anomalies.Attempts were made to interrogate the device, and it was noted the icm could not be communicated with.The device case was removed to facilitate inspection and testing of the internal components.The battery was removed and replaced with an external power source.The current drain was measured and found to be normal.The battery was forwarded for detailed analysis.This analysis identified a latent current leakage path within the battery that resulted in premature battery depletion.This was the reason behind the initially reported message that was displayed.
Event or Problem Description
It was reported that during an insertable cardiac monitor (icm) device implant procedure, initially, it was possible to connect with this icm device.However, after the icm device was implanted, a message was displayed, indicating there was an issue with the icm device.Due to this reason, the device was removed from the patient, prior to pocket closure, and a different icm device was successfully implanted to complete the procedure.No adverse patient effects were reported.The first icm device has been returned and analysis has been completed.

• Brand Name: LUX-DX II?
• 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: 24469803
• Report Number: 2124215-2026-10971
• Device Sequence Number: 15864128
• Product Code: MXD
• UDI-Device Identifier: 00802526620713
• UDI-Public: (01)00802526620713(17)250824
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K231328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: 08/24/2025
• Device Model Number: M302
• Device Catalogue Number: M302
• Device Lot Number: 103676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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: 62 YR
• Patient Sex: Unknown