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

Model Number	4473
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); High impedance (1291); Under-Sensing (1661); High Capture Threshold (3266)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited high out of range pacing impedances measuring above 2500 ohms, with undersensing, high pacing thresholds, noise, and suspected loss of capture with an atrial rhythm of 30 beats per minute caused by a lead fracture.Technical services (ts) was consulted, and programming options were advised.The physician opted to perform the programming enhancements.No additional adverse patient effects were reported.This lead remains in service.
Additional Manufacturer Narrative
This product remains implanted and has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.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.Review of labeling determined the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance with labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.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.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 right atrial (ra) lead exhibited high out of range pacing impedances measuring above 2500 ohms, with undersensing, high pacing thresholds, noise, and suspected loss of capture with an atrial rhythm of 30 beats per minute caused by a lead fracture.Technical services (ts) was consulted, and programming options were advised.The physician opted to perform the programming enhancements.No additional adverse patient effects were reported.This lead remains in service.

• 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: 23026321
• Report Number: 2124215-2025-63884
• Device Sequence Number: 18596845
• Product Code: DTB
• UDI-Device Identifier: 00802526265020
• UDI-Public: (01)00802526265020(17)040125
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: 01/25/2004
• Device Model Number: 4473
• Device Catalogue Number: 4473
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 01/25/2002
• 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: 88 YR
• Patient Sex: Male