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

Model Number	4469
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right atrial (ra) lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The ra lead was explanted.
Event or Problem Description
It was reported that the patient with this right atrial (ra) lead had an infection.A revision was performed and the cardiac resynchronization therapy defibrillator (crt-d) with the right ventricular (rv) lead, right atrial (ra) lead and left ventricular (lv) lead were explanted.No additional adverse patient effects were reported.The ra lead was not returned for analysis.Additional information from the field indicates that the patient was prescribed antibiotics.Additionally, the patient aspirated after the procedure and subsequently passed away as a result.No additional adverse patient effects were reported.

• Brand Name: FINELINE II EZ 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50587571
• Report Number: 2124215-2026-46203
• Device Sequence Number: 9442175
• Product Code: DTB
• UDI-Device Identifier: 00802526265143
• UDI-Public: (01)00802526265143(17)181107
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/07/2018
• Device Model Number: 4469
• Device Catalogue Number: 4469
• Device Lot Number: 601017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 11/07/2016
• 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; Death
• Patient Age: 84 YR
• Patient Sex: Female