MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUX-DX INSERTABLE CARDIAC MONITOR; IMPLANTABLE CARDIAC MONITOR (ICM)

Model Number M301

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

Patient Problems Wound Dehiscence (1154); Erosion (1750)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

This product is not expected to be returned.If the product is returned, analysis would be performed and this report would be updated at that time.

Event Description

It was reported that this implantable cardiac monitor (icm) eroded and was explanted and replaced.The patient reports that he bent over the side of the bed in the morning to pick up a water bottle and felt a pop, he then realized this icm was sticking out of the incision.The replacement procedure took place afterwards.No additional adverse patient effects were reported.

• Brand Name: LUX-DX INSERTABLE CARDIAC MONITOR
• Type of Device: IMPLANTABLE CARDIAC MONITOR (ICM)
• 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: 12113496
• MDR Text Key: 259974674
• Report Number: 2124215-2021-14589
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 00802526607103
• UDI-Public: 00802526607103
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2022
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 121498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR