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

Model Number	0676
Medical Device Problem Codes	Mechanical Problem (1384); Positioning Problem (3009); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead was not successfully implanted due to an unknown product performance anomaly.A new lead with the same model was implanted.No adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental correction report was created to capture the additional information received which indicates that the lead was not successfully implanted due to placement difficulty and helix unable to extend.This observation no longer meets the definition of reportable malfunction.Amending mdr decision to mdr=no report.
Event or Problem Description
It was reported that this right ventricular (rv) lead was not successfully implanted due to an unknown product performance anomaly.A new lead with the same model was implanted.No adverse patient effects were reported.Additional information indicated that this lead was not successfully as the lead was moved a few times to get best sensing and threshold measurements until the helix could not extend.Also, the lead will not be returned.

• 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: 24798869
• Report Number: 2124215-2026-18745
• Device Sequence Number: 9469693
• Product Code: NVY
• UDI-Device Identifier: 00802526497001
• UDI-Public: (01)00802526497001(17)280115
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2026

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: Health Professional
• Device Model Number: 0676
• Device Catalogue Number: 0676
• Device Lot Number: 523190
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/07/2026; 06/02/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/30/2026; 06/23/2026
• Date Device Manufactured: 01/15/2026
• 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: 79 YR
• Patient Sex: Female