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

Model Number	M301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has 2 premarket approvals and due to spacing limitations on field g4 they are k193473 and k210608.
Event or Problem Description
It was reported that a patient with a history of cerebrovascular accident presented with discomfort related to an insertable cardiac monitor (icm).Due to ongoing symptoms, the patient requested device removal and requested icm removal.Additionally, the icm had reached effective replacement status approximately three years and six months after implantation.Battery depletion was consistent with the expected service life, confirming normal device usage.The icm was explanted and returned for analysis.No additional adverse effects were reported for the patient.
Additional Manufacturer Narrative
This device has 2 premarket approvals and due to spacing limitations on field g4 they are k193473 and k210608.01 - the supplemental was opened to report the product analysis results of the device returned.Complaint investigation indicates the product was returned to boston scientific, based on analysis of the returned product.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use (visual inspection found no anomalies, device received with no telemetry and review of latitude data found no suspicious system errors or faults, device meets labeled longevity).Based on the results of the investigation, no escalation is required.
Event or Problem Description
It was reported that a patient with a history of cerebrovascular accident presented with discomfort related to an insertable cardiac monitor (icm).Due to ongoing symptoms, the patient requested device removal and requested icm removal.Additionally, the icm had reached effective replacement status approximately three years and six months after implantation.Battery depletion was consistent with the expected service life, confirming normal device usage.The icm was explanted and returned for analysis.No additional adverse effects were reported for the patient.

• Brand Name: LUX-DX? INSERTABLE CARDIAC MONITOR
• Common Device Name: INSERTABLE CARDIA 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: 23222446
• Report Number: 2124215-2025-70397
• Device Sequence Number: 21244649
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(17)230406
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2025
• 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): 02/18/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/06/2023
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 140126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: 71 YR
• Patient Sex: Male