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	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine follow up, this right ventricular (rv) lead was found to exhibit high pacing thresholds and high pacing impedances within normal limits (wnl).The health care professional (hcp) called technical services (ts) and requested further review of the stored data.Upon review, ts determined that there was a gradual increase in rv lead pacing thresholds and pacing impedances that remained within normal limits (wnl) over the past six months.Ts discussed possible causes with the hcp.At this time, the rv lead remains in service.No adverse patient effects were reported.Subsequently, additional information was received that reported that a lead revision procedure was performed.This right ventricular (rv) lead was explanted and replaced with a new lead due to impedance issues.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual examination of the lead noted calcification of body fluids on the lead tip.Resistance and pressure tests were completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Analysis determined that the increased impedance measurements may have been impacted by the calcification of body fluids on the lead tip.Calcification, the process in which layers of calcium build up on a surface (e.G., leads), is a patient condition that develops over time in some populations.The mechanism of calcification is assumed to be associated with cell devitalization and accumulation of cellular debris following implantation.Past experience has shown that as calcified material builds up on the electrode surfaces of a lead, impedance measurements increase.
Event or Problem Description
It was reported that during a routine follow up, this right ventricular (rv) lead was found to exhibit high pacing thresholds and high pacing impedances within normal limits (wnl).The health care professional (hcp) called technical services (ts) and requested further review of the stored data.Upon review, ts determined that there was a gradual increase in rv lead pacing thresholds and pacing impedances that remained within normal limits (wnl) over the past six months.Ts discussed possible causes with the hcp.At this time, the rv lead remains in service.No adverse patient effects were reported.Subsequently, additional information was received that reported that a lead revision procedure was performed.This right ventricular (rv) lead was explanted and replaced with a new lead due to impedance issues.No additional adverse patient effects were reported.

• 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: 21044955
• Report Number: 2124215-2024-82514
• Device Sequence Number: 3417799
• Product Code: NVY
• UDI-Device Identifier: 00802526592850
• UDI-Public: (01)00802526592850(17)240722(21)191354
• 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
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 04/02/2025

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: 07/22/2024
• Device Model Number: 0662
• Device Catalogue Number: 0662
• Device Lot Number: 191354
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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: 48 YR
• Patient Sex: Male