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

Model Number	M301
Medical Device Problem Codes	Premature Discharge of Battery (1057); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this insertable cardiac monitor (icm) last transmission was over 2 years ago.The healthcare provider indicated that they think that the battery depleted two years after initial implant.The healthcare provider will follow-up with the patient to check if they want their icm replaced.The icm remains in service and no adverse patient effects were reported.
Additional Manufacturer Narrative
G4: pma/510(k) # field on 3500a form contains an additional code - k193473, k210608; both reported here as it exceeded character limit for designated field.
Additional Manufacturer Narrative
G4: pma/510(k) # field on 3500a form contains an additional code - k193473, k210608; both reported here as it exceeded character limit for designated field.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Product record reviews did not identify a product quality issue or new patient harm.Analysis of available information did not identify a specific complaint cause.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 communication or transmission issue 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 review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established.".
Event or Problem Description
It was reported that this insertable cardiac monitor (icm) last transmission was over 2 years ago.The healthcare provider indicated that they think that the battery depleted two years after initial implant.The healthcare provider will follow-up with the patient to check if they want their icm replaced.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 ; 6515826168
• MDR Report Key: 25311811
• Report Number: 2124215-2026-28498
• Device Sequence Number: 13398028
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(17)231006
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: 10/05/2023
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 150702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Unknown