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

Model Number	4457
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
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 the patient with the pacemaker system including this right ventricular (rv) lead presented for a magnetic resonance imaging (mri).The health care professional reported the presenting electrogram exhibited rv loss of capture (loc).A threshold test was completed which also showed rv loc.The patient was not symptomatic and no pauses in pacing were exhibited.The mri was not completed, and the patient was to be evaluated.Additional information has been requested but was not provided at this time.This rv lead remains in service.No adverse patient effects were reported.
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 the patient with the pacemaker system including this right ventricular (rv) lead presented for a magnetic resonance imaging (mri).The health care professional reported the presenting electrogram exhibited rv loss of capture (loc).A threshold test was completed which also showed rv loc.The patient was not symptomatic and no pauses in pacing were exhibited.The mri was not completed, and the patient was to be evaluated.Additional information provided high capture thresholds were exhibited.Outputs were subsequently reprogrammed.This rv lead remains in service.No adverse patient effects were reported.

• 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24268992
• Report Number: 2124215-2026-06584
• Device Sequence Number: 10723643
• Product Code: DTB
• UDI-Device Identifier: 00802526060915
• UDI-Public: (01)00802526060915(17)210305
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 02/06/2026

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: 03/05/2021
• Device Model Number: 4457
• Device Catalogue Number: 4457
• Device Lot Number: 839480
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/06/2026
• Date Device Manufactured: 03/05/2019
• 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: 68 YR
• Patient Sex: Male