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

Model Number	4457
Medical Device Problem Codes	Pacing Problem (1439); Use of Device Problem (1670)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Heart Failure/Congestive Heart Failure (4446)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced system shortness of breath (sob) and fatigue.It was noted there was suspicious pacing behavior observed on the electrograms (egms).It was hypothesized that at the time of the device upgrade in 2023, the old right ventricular (rv) lead was placed incorrectly in the right atrial (ra) port of this crt-d, and the old ra lead was mistakenly surgically abandoned.The physician performed a pocket exploration and confirmed the old rv lead was attached to the atrial port, and the ra lead was abandoned.The rv lead was removed from the atrial port and replaced with the ra lead.It was also noted the patient would continue to be monitored and that the patient had an increase in ejection fraction since the crt-d was implanted.This rv lead was surgically abandoned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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: 50260520
• Report Number: 2124215-2026-43773
• Device Sequence Number: 16120369
• Product Code: DTB
• UDI-Device Identifier: 00802526060915
• UDI-Public: (01)00802526060915(17)210126
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: 01/26/2021
• Device Model Number: 4457
• Device Catalogue Number: 4457
• Device Lot Number: 838660
• 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: 08/05/2026
• Initial Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 01/26/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Male