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

Model Number	0662
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a gradual increase of within range pacing impedance measurements, measuring 1259 ohms.Additionally, this lead exhibited a gradual increase in threshold measurements.At this time, this rv lead remains in service, and no adverse patient effects were reported.Additional information was received that this rv lead continued to exhibit a gradual increase of within range pacing impedance measurements, measuring 1950 ohms.It was noted that the threshold measurements were stable.No adverse patient effects were reported.This rv lead remains in service.Additional information was received that this rv lead was explanted and replaced.No additional adverse patient effects were reported.This rv lead has not returned for analysis.
Additional Manufacturer Narrative
This lead was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the lead, however, a response was not received.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.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.This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a gradual increase of within range pacing impedance measurements, measuring 1259 ohms.Additionally, this lead exhibited a gradual increase in threshold measurements.At this time, this rv lead remains in service, and no adverse patient effects were reported.Additional information was received that this rv lead continued to exhibit a gradual increase of within range pacing impedance measurements, measuring 1950 ohms.It was noted that the threshold measurements were stable.No adverse patient effects were reported.This rv lead remains in service.Additional information was received that this rv lead was explanted and replaced.No additional adverse patient effects were reported.This rv lead has not returned for analysis.

• 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: 25222691
• Report Number: 2124215-2026-27016
• Device Sequence Number: 18592139
• Product Code: NVY
• UDI-Device Identifier: 00802526592850
• UDI-Public: (01)00802526592850(17)250423
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 04/23/2025
• Device Model Number: 0662
• Device Catalogue Number: 0662
• Device Lot Number: 215000
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 04/24/2023
• 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: 70 YR
• Patient Sex: Male