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

Model Number	4456
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
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 right ventricular (rv) lead exhibited a high out of range pacing impedance, greater than 2000 ohms.It was suspected that this rv lead was fractured, however, this was not confirmed.This lead was scheduled to be explanted.During the laser lead extraction procedure, the rv and right atrial (ra) lead became dislodged.Also, the terminal tips of both leads were separated from the lead bodies.The tips were removed from the patient using a snare.This rv lead and ra lead were explanted.Due to the extended procedure, no new leads were implanted at this time.This rv lead was disposed of by the physician.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a high out of range pacing impedance, greater than 2000 ohms.It was suspected that this rv lead was fractured, however, this was not confirmed.This lead was scheduled to be explanted.During the laser lead extraction procedure, the right atrial (ra) lead became dislodged.Also, the terminal tips of both leads were separated from the lead bodies.The tips were removed from the patient using a snare.This rv lead and ra lead were explanted.Due to the extended procedure, no new leads were implanted at this time.This rv lead was disposed of by the physician.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Correction: b5, f10, and h6.
Additional Manufacturer Narrative
This product was explanted but was not returned.As such, physical analysis has not been conducted in our laboratory.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.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, the conclusion code known inherent risk of device was assigned, it can be concluded that expected or well-understood factors most probably contributed to the event.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a high out of range pacing impedance, greater than 2000 ohms.It was suspected that this rv lead was fractured, however, this was not confirmed.This lead was scheduled to be explanted.During the laser lead extraction procedure, the right atrial (ra) lead became dislodged.Also, the terminal tips of both leads were separated from the lead bodies.The tips were removed from the patient using a snare.This rv lead and ra lead were explanted.Due to the extended procedure, no new leads were implanted at this time.This rv lead was disposed of by the physician.No additional 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: 24135316
• Report Number: 2124215-2026-03896
• Device Sequence Number: 10394887
• Product Code: DTB
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/13/2016
• Device Model Number: 4456
• Device Catalogue Number: 4456
• Device Lot Number: 528707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 03/10/2026; 04/30/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/10/2026; 05/04/2026
• Date Device Manufactured: 05/13/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female