MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; PERMANENT PACEMAKER ELECTRODE

Model Number	4456
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this rv lead exhibiting high thresholds and an increase in pace impedance measurements that remained within range.The configuration was switched to unipolar and threshold and impedances returned to previous levels.This rv lead remains in service.No adverse patient effects were reported.Additional information was received that this rv lead exhibited a pace impedance measurement that went high out of range resulting in a lead safety switch (lss).There is no evidence of rv lead noise at this time.This patient is only one percent rv paced so technical services (ts) discussed it is up to the clinic for the next steps.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The device was not returned for analysis, as it remains in service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk.
Additional Manufacturer Narrative
The device was not returned for analysis, as it remains in service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk.
Event or Problem Description
It was reported that this rv lead exhibiting high thresholds and an increase in pace impedance measurements that remained within range.The configuration was switched to unipolar and threshold and impedances returned to previous levels.This rv lead remains in service.No adverse patient effects were reported.Additional information was received that this rv lead exhibited a pace impedance measurement that went high out of range resulting in a lead safety switch (lss).There is no evidence of rv lead noise at this time.This patient is only one percent rv paced so technical services (ts) discussed it is up to the clinic for the next steps.This rv lead remains in service.No adverse patient effects were reported.Additional information was received that the rv pace impedance measurements had gradually been rising.The physician and health care professional (hcp) were wanting this patient to undergo a magnetic resonance imaging (mri) however ts discussed there can be no evidence of a lead fracture in order to do so.The physician was considering reprogramming to bipolar configuration as there has not been any rv lead noise and all other lead measurements were within normal range.This rv lead remains in service.

• Brand Name: FINELINE II STEROX
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• 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: 24557894
• Report Number: 2124215-2026-13105
• Device Sequence Number: 15785631
• Product Code: DTB
• UDI-Device Identifier: 00802526087752
• UDI-Public: 00802526087752
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

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: 10/02/2016
• Device Model Number: 4456
• Device Catalogue Number: 4456
• Device Lot Number: 531176
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 05/29/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/13/2026; 06/01/2026
• Date Device Manufactured: 10/02/2014
• 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
• Patient Age: 58 YR
• Patient Sex: Male