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

Model Number L331

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

Patient Problems Headache (1880); Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.

Event Description

It was reported that this implantable pacemaker device was explanted due to venous occlusion.No additional adverse patient effects were reported.Additional information from the field indicates that the patient also experienced superior vena cava syndrome (svcs) due to the occlusion.Bilateral upper extremity swelling, headaches, unable to lie flat.Worsened with activity.Leads in the vein were believed to be the cause.

• Brand Name: ACCOLADE MRI EL DR
• Type of Device: IMPLANTABLE PACEMAKER 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: 19183582
• MDR Text Key: 341063838
• Report Number: 2124215-2024-25122
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2022
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 875088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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): Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female