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

Model Number	M301
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this insertable cardiac monitor (icm) was disable due to possible device malfunction.Boston scientific technical services indicated that based on the date and time between the last connection and the implant date, the icm probably had reach the end of service (eos) status; however, the alert was a partial upload.The healthcare provider confirmed that patient had missed last two schedule transmission.The icm remains in service and no adverse patient effects were reported.

• 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 ; +1(651)582-6168
• MDR Report Key: 25001702
• Report Number: 2124215-2026-22558
• Device Sequence Number: 21275523
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(17)240711
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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: 07/11/2024
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 174580
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 01/23/2023
• 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: 56 YR
• Patient Sex: Unknown