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

Model Number	4456
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device remains in service and was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that this patient with a right ventricular (rv) lead experienced a syncopal episode.Technical services (ts) reviewed the data and noted there was oversensing on the right ventricular (rv) channel.There was also noise on the rv channel which ts suspected to be myopotentials.Ts also noted that during the recorded oversensing there were clear intrinsic beats visible and as such no pacing inhibition.Ts further noted there was no obvious device cause of the syncopal episode.Ts recommended a full lead evaluation and suggested reprogramming options.This rv lead remains in service and 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: 24911336
• Report Number: 2124215-2026-20893
• Device Sequence Number: 21314348
• Product Code: DTB
• UDI-Device Identifier: 00802526087752
• UDI-Public: (01)00802526087752(17)110911
• 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: 2009
• 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): 04/17/2026

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: 09/11/2011
• Device Model Number: 4456
• Device Catalogue Number: 4456
• Device Lot Number: 487833
• 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: 03/29/2026
• Initial Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 09/11/2009
• 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: 61 YR
• Patient Sex: Female