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

Model Number	M302
Medical Device Problem Codes	False Negative Result (1225); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the insertable cardiac monitor (icm) did not record any af events.Technical service reviewed the case with the representative, who inquired why no af events were recorded despite reported af burden episodes.Af detection was programmed to 4 minutes, and no recent programming changes were identified.It is possible that the episodes did not meet the programmed detection criteria.Engineering reviewed the case and determined that the missing episode was most likely associated with unrecoverable payload failures.The icm remains in service, and no adverse patient effects were reported.

• 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 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: 50910575
• Report Number: 2124215-2026-51330
• Device Sequence Number: 5776818
• Product Code: MXD
• UDI-Device Identifier: 00802526620713
• UDI-Public: (01)00802526620713(17)260225
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K231328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2026

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: 02/25/2026
• Device Model Number: M302
• Device Catalogue Number: M302
• Device Lot Number: 108794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 09/10/2024
• 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: 69 YR
• Patient Sex: Male