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

Model Number	4471
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker was alerted that a lead safety switch (lss) from bipolar to unipolar configurations was triggered due to high out of range pacing impedance measurements on the right ventricular (rv) lead were recorded.The health care professional (hcp) called technical services (ts) for further review of daily threshold and impedance measurements trend report.Upon review, the device data showed rv lead pacing impedances were stable within normal limits except for two instances that caused the lss.The presenting electrogram (egm) showed no noise events and isometrics was unable to reproduce the high out of range pacing impedances.Ts discussed possible causes and provided programming recommendations.No adverse patient effects were reported.At this time, this rv lead and pacemaker remain in service.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• 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): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50873392
• Report Number: 2124215-2026-50758
• Device Sequence Number: 13447557
• Product Code: DTB
• UDI-Device Identifier: 00802526265006
• UDI-Public: (01)00802526265006(17)081120
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 11/20/2008
• Device Model Number: 4471
• Device Catalogue Number: 4471
• Device Lot Number: 445555
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 11/20/2006
• 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