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

Model Number	4457
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during evaluation prior to a magnetic resonance imaging (mri) procedure, the patient with this right ventricular (rv) lead exhibited pacing impedance measurements slightly above 2000 ohms.Technical services (ts) reviewed the device data and confirmed that the impedance values have remained stable around this value since approximately three years prior.Based on the available data, device function appears stable; however, the decision to proceed with the mri remains clinical.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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25071269
• Report Number: 2124215-2026-23924
• Device Sequence Number: 10695450
• Product Code: DTB
• UDI-Device Identifier: 00802526060915
• UDI-Public: (01)00802526060915(17)021220
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 12/20/2002
• Device Model Number: 4457
• Device Catalogue Number: 4457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/04/2026
• Date Device Manufactured: 12/20/2000
• 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: 72 YR
• Patient Sex: Male