MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II EZ Sterox; Implantable Lead

Model Number	4471
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	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pacemaker and this right ventricular (rv) lead right ventricular automatic threshold (rvat) test was suspended due to a loss of capture.Also, technical services (ts) suspected this pacemaker stored inappropriate ventricular episodes due to an atrial arrythmia with rapid ventricular response (rvr).Ts also noted the last rvat was above programmed outputs and was trending upwards.Ts discussed the loss of capture with the health care professional (hcp).The hcp planned to consult with cardiology.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50897299
• Report Number: 2124215-2026-51160
• Device Sequence Number: 6026516
• Product Code: DTB
• UDI-Device Identifier: 00802526265006
• UDI-Public: (01)00802526265006(17)060625
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 06/25/2006
• Device Model Number: 4471
• Device Catalogue Number: 4471
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 06/25/2004
• 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: 66 YR
• Patient Sex: Male