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

Model Number	4472
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Failure to Read Input Signal (1581); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) for further review of this pacemaker presenting electrogram (egm) due to concerns of loss of capture (loc) on the right atrial (ra) lead.Upon review, intermittent ra loc, farfield r-wave oversensing and possible atrial undersensing were observed.Ts recommended to the hcp to schedule an in person visit for further device evaluation and recommended reprogramming options.At this time, the pacemaker and ra lead remain in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) for further review of this pacemaker presenting electrogram (egm) due to concerns of loss of capture (loc) on the right atrial (ra) lead.Upon review, intermittent ra loc, farfield r-wave oversensing and possible atrial undersensing were observed.Ts recommended to the hcp to schedule an in person visit for further device evaluation and recommended reprogramming options.At this time, the pacemaker and ra lead remain in service.No adverse patient effects were reported.Subsequent additional information was received from the field representative that reported, during a follow up clinic visit, this right atrial (ra) lead was checked, and ra sensing was reprogrammed by the physician due to intermittent low amplitude ra signals.The physician was unable to confirm ra capture threshold.It is believed cause to be due to functional non-capture or electrically dead atrial tissue.The ra lead remains in service.No adverse patient effects were reported.

• 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 21596404
• Report Number: 2124215-2025-15709
• Device Sequence Number: 8219628
• Product Code: DTB
• UDI-Device Identifier: 00802526265013
• UDI-Public: 00802526265013
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 01/13/2013
• Device Model Number: 4472
• Device Catalogue Number: 4472
• Device Lot Number: 428050
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/19/2025
• Date Device Manufactured: 01/13/2011
• 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 Sex: Male