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

Model Number	4456
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Codes	Fall (1848); Dizziness (2194); Syncope/Fainting (4411)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) for programming assistance.The hcp reported that the patient with this pacemaker system presented to the emergency room (er) due to syncope from right ventricular (rv) lead loss of capture (loc).Ts reviewed device settings and provided programming optimization options.The hcp performed commanded auto threshold and reprogrammed the device.The hcp will continue with monitoring.No adverse patient effects were reported.This rv lead remains in service.

• 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: 25452062
• Report Number: 2124215-2026-30876
• Device Sequence Number: 10450160
• Product Code: DTB
• UDI-Device Identifier: 00802526087752
• UDI-Public: (01)00802526087752(17)121210
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/10/2012
• Device Model Number: 4456
• Device Catalogue Number: 4456
• Device Lot Number: 494954
• Was Device Available for Evaluation?: No
• 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: 05/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 08/21/2026
• Date Device Manufactured: 12/10/2010
• 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
• Patient Age: 87 YR
• Patient Sex: Male