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 Problem Hemorrhage/Bleeding (1888)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department (ed) following an insertable cardiac monitor (icm) device implant procedure.The patient was bleeding at the implant site.The patient was admitted to the hospital.Laboratory tests were administered and the patient received an x-ray.A washout of the icm pocket was preformed and the pocket closed.The patient has since been discharged from the hospital.The device remains in service at this time.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: 19166642
• MDR Text Key: 340860432
• Report Number: 2124215-2024-24628
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• 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: 198632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 50 KG