MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUX-DX INSERTABLE CARDIAC MONITOR; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION)

Model Number M301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that the insertable cardiac monitor (icm) was explanted due to an infection at the implant site.Another icm was implanted as a replacement.The device remains in possession by the customer and will not be returned.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction field b5: describe event or problem, and h6: patient codes.

Event Description

It was reported that the insertable cardiac monitor (icm) was explanted due to an infection and erosion of the skin around the implant site.Another icm was implanted as a replacement.The device remains in possession by the customer and will not be returned.No additional adverse patient effects were reported.

• Brand Name: LUX-DX INSERTABLE CARDIAC MONITOR
• Type of Device: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION)
• 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: 18912461
• MDR Text Key: 337759335
• Report Number: 2124215-2024-15805
• Device Sequence Number: 1
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: 00802526607103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 177826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male