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 Wound Dehiscence (1154); Erosion (1750)

Event Date 10/31/2023

Event Type  Injury  

Event Description

It was reported that this insertable cardiac monitor (icm) device was explanted.The patient called boston scientific technical services (ts).The patient reported they came to the clinic for a scheduled post-implant check.Upon review the physician found the icm device had partially come out of the chest of the patient.Physician noted the icm device had eroded and chose to explant the icm device.No other devices have been implanted at this time.Device has not been 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: 18439855
• MDR Text Key: 331841235
• Report Number: 2124215-2024-00203
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• 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: 194932
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male