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 Wound Dehiscence (1154)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that the insertable cardiac monitor (icm) fell out of the patient pocket.Another icm was implanted successfully as a replacement.No 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: 18946584
• MDR Text Key: 338185255
• Report Number: 2124215-2024-17096
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 194469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 81 YR