MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II Sterox; Implantable lead

Model Number	4456
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead was part of a system revision due to systemic infection.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.This rv lead was explanted.

• Brand Name: FINELINE II Sterox
• Common Device Name: Implantable lead
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25379690
• Report Number: 2124215-2026-29711
• Device Sequence Number: 9463137
• Product Code: DTB
• UDI-Device Identifier: 00802526087752
• UDI-Public: (01)00802526087752(17)271220
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 4456
• Device Catalogue Number: 4456
• Device Lot Number: 546195
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male