MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD

Model Number 0673

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

Patient Problems Fever (1858); Unspecified Infection (1930); Swelling (2091); No Code Available (3191)

Event Date 10/24/2020

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.(b)(4).

Event Description

It was reported that this right ventricular (rv) lead was explanted due to infection.The patient underwent surgical intervention to explant the lead.No additional adverse patient effects were reported.The lead is not expected to return.

Event Description

It was reported that this right ventricular (rv) lead was explanted due to infection.The patient presented a fever and when checked, the pocked was swollen.The patient underwent surgical intervention to explant the lead.No additional adverse patient effects were reported.The lead is not expected to return.

Manufacturer Narrative

This supplemental report was filled to correct field b5: "describe event or problem", field e1: "initial reporter phone" and field h6: "patient codes".At this time, the product has not been returned.Patient code 3191 captures the reportable event of surgery.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11104257
• MDR Text Key: 224741323
• Report Number: 2124215-2020-25554
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/15/2022
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 121442
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention