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

Model Number	4474
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this right ventricular (rv) lead triggered a lead safety switch due to high out of range pacing impedance measurements.The physician provided this rv lead was fractured.During isometric testing noise was oversensed and resulted in pacing inhibition.Subsequently, this rv lead was surgically abandoned.Another lead was placed in the rv to complete this procedure.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead triggered a lead safety switch due to high out of range pacing impedance measurements.The physician provided this rv lead was fractured.During isometric testing noise was oversensed and resulted in pacing inhibition.Subsequently, this rv lead was surgically abandoned.Another lead was placed in the rv to complete this procedure.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This correction report was submitted due to changes in the h6, impact codes field.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this right ventricular (rv) lead triggered a lead safety switch due to high out of range pacing impedance measurements.The physician provided this rv lead was fractured.During isometric testing noise was oversensed and resulted in pacing inhibition.Subsequently, this rv lead was surgically abandoned.Another lead was placed in the rv to complete this procedure.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.It was confirmed that this device met manufacturing specifications prior to distribution and there was no indication that the device manufacturing process contributed to the reported complaint.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of fracture was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• Brand Name: FINELINE II EZ 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: 23357287
• Report Number: 2124215-2025-75540
• Device Sequence Number: 21048881
• Product Code: DTB
• UDI-Device Identifier: 00802526265037
• UDI-Public: (01)00802526265037(17)051022
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

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: 10/22/2005
• Device Model Number: 4474
• Device Catalogue Number: 4474
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 11/16/2025; 04/24/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/19/2025; 04/24/2026
• Date Device Manufactured: 10/22/2003
• 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; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male