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

Model Number	M301
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this insertable cardiac monitor (icm) was having connection issues.It was indicated that battery could be beyond end of service (eos) according to implant date.The patient was referred to the clinic for device check.The icm remains in service and no adverse patient effects were reported.Additional information revealed that the patient presented in the clinic, but the icm was unable to connect.The patient was upset and insisted on having it removed.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Field g4 premarket/510k, from section g all manufacturers, contains both documents k193473 and k210608 whose character limit prevented both entries from the field.

• 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: 25429730
• Report Number: 2124215-2026-30402
• Device Sequence Number: 10241983
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(17)240516
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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 Expiration Date: 05/16/2024
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 169102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 07/27/2026; 07/30/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 07/29/2026; 07/30/2026
• Date Device Manufactured: 11/24/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Unknown