MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUX-DX II+?; INSERTABLE CARDIAC MONITOR

Model Number	M312
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a newly delivered insertable cardiac monitor (icm) device was reported to have been handed to the representative two days prior.During initial interrogation, the device unexpectedly displayed an end of service (eos) status, despite not being implanted.Technical services recommended against implantation and instructed that the device be returned for analysis, as the cause of the premature eos is currently unknown.The icm was never implanted, and no patient was involved.
Additional Manufacturer Narrative
This supplemental 01 - updated the results of the device evaluation: this insertable cardiac monitor (icm) device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device identified anomalies.Visual inspection revealed no anomalies.Security keys were scrubbed, and a memory dump was performed.Battery diagnostics indicated an end-of-service condition due to intermittent voltage readings below the threshold, confirming the reported failure.Returned product testing verified normal operation of all device functions, and the unit passed.Analysis of device data found low rf voltage measurement below threshold triggering eos.The cause was not determined.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.A risk review was completed and confirmed that the event of premature discharge of battery 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.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 to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough analysis of the returned device and review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that a newly delivered insertable cardiac monitor (icm) device was reported to have been handed to the representative two days prior.During initial interrogation, the device unexpectedly displayed an end of service (eos) status, despite not being implanted.Technical services recommended against implantation and instructed that the device be returned for analysis, as the cause of the premature eos is currently unknown.The icm was never implanted, and no patient was involved.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23062857
• Report Number: 2124215-2025-64833
• Device Sequence Number: 14356255
• Product Code: MXD
• UDI-Device Identifier: 00802526620706
• UDI-Public: (01)00802526620706(17)270124
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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 Model Number: M312
• Device Catalogue Number: M312
• Device Lot Number: 158353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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