MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUX-Dx II?; Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

Model Number	M302
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this insertable cardiac monitor (icm) was explanted due to infection.No new device was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this insertable cardiac monitor (icm) was explanted due to infection.No new device was implanted.No additional adverse patient effects were reported.Additional information revealed that this insertable cardiac monitor (icm) was not explanted due to infection but rather it migrated out of the insertion site.The icm will not returned.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this insertable cardiac monitor (icm) was explanted due to infection.No new device was implanted.No additional adverse patient effects were reported.\ \ additional information revealed that this insertable cardiac monitor (icm) was not explanted due to infection but rather it migrated out of the insertion site.The icm will not returned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This report is report is being submitted to correct the report source field (g2) in section g, all manufacturers.\ \ this product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Product record reviews did not identify a product quality issue or new patient harm.The primary reported observation is addressed in product labeling.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of migration was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of \"known inherent risk of device\".

• Brand Name: LUX-Dx II?
• Common Device Name: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 24690021
• Report Number: 2124215-2026-16375
• Device Sequence Number: 9706597
• Product Code: MXD
• UDI-Device Identifier: 00802526620713
• UDI-Public: (01)00802526620713(17)270604
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K231328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2026

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 Model Number: M302
• Device Catalogue Number: M302
• Device Lot Number: 124227
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 07/27/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/15/2026; 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown