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

Model Number	4456
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a burning sensation with this right ventricular (rv) lead which was out of place.The boston scientific technical services consultant referred the patient to the clinic.As of this time, this rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product was manufactured before the implementation of the udi regulation, so the complete udi is unavailable.Applicable us product data has been included in this report.

• 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: 50335464
• Report Number: 2124215-2026-44809
• Device Sequence Number: 5702284
• Product Code: DTB
• UDI-Device Identifier: 00802526087752
• UDI-Public: (01)00802526087752(17)150421
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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: 04/21/2015
• Device Model Number: 4456
• Device Catalogue Number: 4456
• Device Lot Number: 522133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Date Device Manufactured: 04/21/2013
• 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
• Patient Age: 83 YR
• Patient Sex: Female