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

Model Number	4457
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
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 this pacemaker system triggered a lead safety switch (lss) on the right ventricular (rv) lead due to an abrupt high out of range pacing impedance measurement in the bipolar configuration, measuring greater than 3000 ohms.The health care professional (hcp) was unable to recreate the out of range measurement in bipolar; however, it was noted that unipolar pacing impedance measured at about 2200 ohms.Minimal noise was observed in bipolar, and loss of capture (loc) was exhibited in unipolar and bipolar.The hcp implemented programming changes that technical services (ts) recommended.Prior to the lss, it was noted that the patient experienced a fall.Subsequently, ts suspected there was a lead fracture and recommended performing a chest x-ray.No adverse patient effects were reported.This rv lead remains in service.
Event or Problem Description
It was reported that this pacemaker system triggered a lead safety switch (lss) on the right ventricular (rv) lead due to an abrupt high out of range pacing impedance measurement in the bipolar configuration, measuring greater than 3000 ohms.The health care professional (hcp) was unable to recreate the out of range measurement in bipolar; however, it was noted that unipolar pacing impedance measured at about 2200 ohms.Minimal noise was observed in bipolar, and loss of capture (loc) was exhibited in unipolar and bipolar.The hcp implemented programming changes that technical services (ts) recommended.Prior to the lss, it was noted that the patient experienced a fall.Subsequently, ts suspected there was a lead fracture and recommended performing a chest x-ray.No adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
This lead was not returned for analysis, as it remains implanted and in service; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of pacing impedance high out of range was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 24652016
• Report Number: 2124215-2026-15597
• Device Sequence Number: 10008547
• Product Code: DTB
• UDI-Device Identifier: 00802526060915
• UDI-Public: (01)00802526060915(17)080831
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• 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): 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: 08/31/2008
• Device Model Number: 4457
• Device Catalogue Number: 4457
• Device Lot Number: 520279
• 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: 05/29/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 08/31/2006
• 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: 73 YR
• Patient Sex: Male