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); Hemorrhage/Bleeding (1888)

Event Date 11/21/2023

Event Type  Injury  

Event Description

It was reported that this insertable cardiac monitor (icm) device was explanted.The physician alerted the boston scientific representative that days after the icm device implant procedure the patient was seen at the emergency room.The bandage over the incision site was soaked with blood.The patient was subsequently seen at the clinic.The clinic removed the bandage and found the incision was open.The physician chose to explant the icm device and start the patient on antibiotics.The physician plans to implant a new icm device in two weeks.The device was not returned for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that days after the insertable cardiac monitor (icm) device implant procedure the patient was seen at the emergency room.The bandage over the incision site was soaked with blood.The patient was subsequently seen at the clinic.The clinic removed the bandage and found the incision was open.The physician chose to explant the icm device and start the patient on antibiotics.The physician plans to implant a new icm device in two weeks.The device has been returned for analysis.No other devices have been implanted at this time.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: 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: 18218832
• MDR Text Key: 329144737
• Report Number: 2124215-2023-67148
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2024
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 165305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR