MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; IMPLANTABLE LEAD

Model Number	4456
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384); Difficult to Remove (1528); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this right ventricular (rv) lead underwent removal of a pacemaker generator due to normal battery depletion (nbd) and extraction of a right ventricular lead that was densely adherent within the subclavian vein and myocardium.After initial attempts of retraction failed, alternating use of a laser sheath and a mechanical cutting tool successfully freed the lead from multiple binding sites.The lead was fractured.Fluoroscopic visualization of the rv was performed.The lead was ultimately separated from the myocardium and withdrawn without complication.A new dual chamber pacemaker was then implanted, the pocket was revised and closed, and the patient was transferred to recovery in stable condition.The lead was successfully explanted and replaced.No additional adverse patient effects were reported.

• 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25318055
• Report Number: 2124215-2026-28630
• Device Sequence Number: 9920307
• Product Code: DTB
• UDI-Device Identifier: 00802526087752
• UDI-Public: (01)00802526087752(17)180428
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 04/28/2018
• Device Model Number: 4456
• Device Catalogue Number: 4456
• Device Lot Number: 538743
• 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: 05/01/2026
• Initial Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 04/28/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female