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

Model Number	0650
Medical Device Problem Codes	Fracture (1260); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to lead was fractured.A new lead was implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to lead was fractured.A new lead with was implanted.No additional adverse patient effects were reported.Additional information indicates that this fracture was confirmed by lead measurements and an x-ray.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.The lead was returned in two segments.Visual inspection showed cuts in insulation likely explant damage.The proximal end of the distal high voltage coil has been separated from the insulation.A deformation was noted in the distal high voltage coupler where it has been flattened.In addition, a light residual calcification was observed on the lead at the tip and shock coil.Testing was completed to assess lead electrical performance.Measurements throughout these tests were within normal limits.Furthermore, laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to lead was fractured.A new lead with was implanted.No additional adverse patient effects were reported.Additional information indicates that the rv lead fracture was confirmed by lead measurements and an x-ray.

• 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: 22920756
• Report Number: 2124215-2025-60846
• Device Sequence Number: 13359490
• Product Code: NVY
• UDI-Device Identifier: 00802526592843
• UDI-Public: (01)00802526592843(17)210124
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• 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): 02/09/2026

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: 01/24/2021
• Device Model Number: 0650
• Device Catalogue Number: 0650
• Device Lot Number: 101199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 01/12/2026
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/22/2025; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2019
• 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: 74 YR
• Patient Sex: Male