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

Model Number	M312
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this insertable cardiac monitor (icm) trigger and alert that indicated "icm insertion not recommended due to low battery condition, prior to implant.Boston scientific technical services indicated to not implant the icm and return it.No adverse patient effects were reported.Additional information indicated that there was no particular patient attach to this icm.The representative was checking on the statues of multiple icms when this icm was found to present this alert.No patient involvement.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.The supplemental report 002 updated the type of reportable event (h1) on the device manufacturers only tab and the occupation (e3) on the initial reporter tab.

• 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: 50602173
• Report Number: 2124215-2026-47188
• Device Sequence Number: 10634653
• Product Code: MXD
• UDI-Device Identifier: 00802526620706
• UDI-Public: (01)00802526620706(17)260905
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/22/2026

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: Other
• Device Expiration Date: 09/05/2026
• Device Model Number: M312
• Device Catalogue Number: M312
• Device Lot Number: 143160
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; 09/04/2026; 09/21/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/04/2026; 09/14/2026; 09/22/2026
• Date Device Manufactured: 03/24/2025
• 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 Sex: Unknown