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

Model Number	M302
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Our investigation determined that the device did not collect pvc burden data following a replacement from a lux-dx device.Boston scientific determined that a programming settings discrepancy can occur in patients who were enrolled in latitude clarity prior to an (b)(6) 2023 system update, and then underwent device replacement from a lux-dx device to a lux-dx ii or lux-dx ii+ device.This can result in certain data not being monitored or collected as expected in the new device.Boston scientific has issued a field safety notice to notify physicians of the potential for certain lux-dx ii & lux-dx ii+ devices to exhibit this behavior.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.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 review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause traced to device design".
Event or Problem Description
It was reported that the patient with this insertable cardiac monitor (icm) had a pvc burden monitoring enable approximately 4 months ago.However, subsequent transmissions continued to show that pvc burden monitor was off.Boston scientific technical services confirmed that pvc monitoring was programmed and accepted by the icm.However, a discrepancy was noted between the programmed settings and what was been displayed in the latitude clarity system.The issue remains unresolved and it is under investigation.The icm remains in service and no adverse patient effects were reported.Additional information indicated that programming for pvc did not take effect at the time of the initial activation due to a system issue.It was confirmed that monitoring for pvc has been activated since the setting was modified back when the initial allegation was made.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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24896010
• Report Number: 2124215-2026-20571
• Device Sequence Number: 10012128
• Product Code: MXD
• UDI-Device Identifier: 00802526620713
• UDI-Public: (01)00802526620713(17)260327
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: 03/27/2026
• Device Model Number: M302
• Device Catalogue Number: M302
• Device Lot Number: 109787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 10/08/2024
• 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: Unknown