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

Model Number	4479
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due other/non product experience.The procedure was successfully performed and a new lv lead was implanted instead.Not further details were provided.No additional adverse patient effects were reported outside the revision procedure.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due other/non product experience.The procedure was successfully performed and a new lv lead was implanted instead.Not further details were provided.No additional adverse patient effects were reported outside the revision procedure.
Additional Manufacturer Narrative
Follow up report 1 (correction): this report is being submitted to correct section d, as the model and serial number has been updated.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due other/non product experience.The procedure was successfully performed and a new lv lead was implanted instead.Not further details were provided.No additional adverse patient effects were reported outside the revision procedure.Additional information was received that the patient with this rv lead experienced diaphragmatic stimulation which caused pain.The patient received morphine as treatment.The patient reported that they had previously experienced the issue of diaphragmatic stimulation, so pacing had been disabled for a lead, with the other lead still pacing.The lead responsible for the diaphragmatic stimulation was not specified.Subsequently this lead was explanted.A new lead was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update field b5: describe event or problem, section b and field h6: device codes, section h.

• 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: 21978650
• Report Number: 2124215-2025-29395
• Device Sequence Number: 21124743
• Product Code: DTB
• UDI-Device Identifier: 00802526061936
• UDI-Public: (01)00802526061936(17)161120
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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: 11/20/2016
• Device Model Number: 4479
• Device Catalogue Number: 4479
• Device Lot Number: 478349
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 03/01/2026
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/08/2025; 03/20/2026
• Date Device Manufactured: 11/20/2014
• 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
• Patient Age: 46 YR
• Patient Sex: Male