MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; IMPLANTABLE DEVICE

Model Number L311

Device Problem Migration (4003)

Patient Problem Twiddlers Syndrome (4563)

Event Date 04/27/2022

Event Type  Injury  

Event Description

It was reported that it was not possible to get threshold on the leads.It was suspected that the leads have pulled back due to the patient having twiddle syndrome.It was confirmed via x-ray that both leads were in the pocket.It was later confirmed that the system of pacemaker device and both right atrial (ra) lead and right ventricular (rv) lead were explanted and replaced with a leadless pacer in its place.No adverse patient effects were reported.

• Brand Name: ACCOLADE MRI DR
• Type of Device: IMPLANTABLE DEVICE
• 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: 14528843
• MDR Text Key: 293001991
• Report Number: 2124215-2022-18154
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2023
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 584214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR