MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT?; Implantable Lead

Model Number	0675
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this recently implanted right ventricular (rv) lead exhibited high capture thresholds.Technical services (ts) was consulted and determined the measurements rose overnight and due to the patient being dependent, the physician and local field representative opted to reposition the lead.Ts discussed programming the system to the left ventricular only but advised against it as the rv port would remain active and could cause oversensing of signals and reset timing cycles.Ts recommended using cautery mode due to the system being biventricular.No additional adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.The lead was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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; PR 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50237357
• Report Number: 2124215-2026-43464
• Device Sequence Number: 16026575
• Product Code: NVY
• UDI-Device Identifier: 00802526496981
• UDI-Public: (01)00802526496981(17)280321
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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 Model Number: 0675
• Device Catalogue Number: 0675
• Device Lot Number: 517057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 03/22/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male