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

Model Number	M301
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the insertable cardiac monitor (icm) was returned to bsc with no initial allegation.The icm was returned bsc.No adverse patient effects were reported.
Additional Manufacturer Narrative
This icm 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.The current drain was measured and found to be normal.The battery was forwarded for detailed analysis.This analysis identified a torn cathode bag internal within the battery that resulted in the observed premature battery depletion.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "manufacturing deficiency".

• 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: 25820444
• Report Number: 2124215-2026-37813
• Device Sequence Number: 21448263
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(11)201118(17)220428
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K193473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 07/14/2026

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: 04/28/2022
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 118239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Unknown