MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUX-Dx II+?; Insertable Cardiac Monitor

Model Number	M312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the insertable cardiac monitor (icm) was explanted due to infection, as required.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.Device technical analysis: this product has not been returned to boston scientific and as a result, laboratory analysis could not be conducted.Device history record review: 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.Risk review: a risk review was completed and confirmed that the event of infection 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.Labeling review: 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 with labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• 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 MN E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50600346
• Report Number: 2124215-2026-46452
• Device Sequence Number: 10742159
• Product Code: MXD
• UDI-Device Identifier: 00802526620706
• UDI-Public: (01)00802526620706(17)271010
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: M312
• Device Catalogue Number: M312
• Device Lot Number: 187688
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/08/2026; 09/09/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/10/2026; 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male