MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT?; IMPLANTABLE LEAD

Model Number	0676
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to a product performance issue.This rv lead was successfully explanted and replaced with another lead.No additional adverse patient effects were reported outside the revision procedure.
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to a product performance issue.This rv lead was successfully explanted and replaced with another lead.No additional adverse patient effects were reported outside the revision procedure.Additional information was received that this rv lead was explanted due to a lead fracture and high capture thresholds.No additional adverse patient effects were reported outside the revision.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update field b5: describe event or problem, section b and field h6: device codes, section h.
Additional Manufacturer Narrative
The complaint device was not returned to bsc; therefore, product 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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to a product performance issue.This rv lead was successfully explanted and replaced with another lead.No additional adverse patient effects were reported outside the revision procedure.Additional information was received that this rv lead was explanted due to a lead fracture and high capture thresholds.No additional adverse patient effects were reported outside the revision.

• Brand Name: RELIANCE 4-FRONT?
• 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: 24694410
• Report Number: 2124215-2026-16495
• Device Sequence Number: 10046990
• Product Code: NVY
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

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: 02/21/2022
• Device Model Number: 0676
• Device Catalogue Number: 0676
• Device Lot Number: 503807
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 06/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 03/31/2026; 06/25/2026
• Date Device Manufactured: 02/21/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male