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

Model Number M312

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

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported that this insertable cardiac monitor (icm) device was explanted.The patient was seen at the clinic one week after initial implant.The icm device was partially hanging out of the body of the patient.The healthcare provider (hcp) reported there was an infection and the site was slightly purulent.The hcp then explanted the icm device.The patient was prescribed antibiotics to treat the infection.No other devices have been implanted at this time.The device is expected to be returned.No additional adverse patient effects were reported.

Event Description

It was reported that the patient was seen at the clinic one week after initial implant.The insertable cardiac monitor (icm) device was partially hanging out of the body of the patient.The healthcare provider (hcp) reported there was an infection and the site was slightly purulent.The hcp then explanted the icm device.The patient was prescribed antibiotics to treat the infection.No other devices have been implanted at this time.The device has been returned.No additional adverse patient effects were reported.

Manufacturer Narrative

This icm was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device identified no anomalies.Testing was completed to assess sensing and device functionality.Measurements throughout these tests were within normal limits.Detailed analysis suggests clinical observations are a known medical risk.

• Brand Name: LUX-DX INSERTABLE CARDIAC MONITOR
• Type of Device: 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: 18268555
• MDR Text Key: 329743673
• Report Number: 2124215-2023-68859
• Device Sequence Number: 1
• Product Code: MXD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M312
• Device Catalogue Number: M312
• Device Lot Number: 101220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male