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

Model Number	0676
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one of the leads was disconnected.Patient is scheduled for a procedure.This lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that one of the leads was disconnected.Patient is scheduled for a procedure.This lead remains in service.No adverse patient effects were reported.Additional information indicated that this right ventricular (rv) lead exhibited high pacing threshold.Also, no pauses were noted due to loss of capture (loc) or noise.The lead was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that one of the leads was disconnected.Patient is scheduled for a procedure.This lead remains in service.No adverse patient effects were reported.Additional information indicated that this right ventricular (rv) lead exhibited high pacing threshold.Also, no pauses were noted due to loss of capture (loc) or noise.The lead was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner and outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.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.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.A risk review was completed and confirmed that the event of dislodged or dislocated was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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.

• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 24654093
• Report Number: 2124215-2026-15649
• Device Sequence Number: 12259391
• Product Code: NVY
• UDI-Device Identifier: 00802526497001
• UDI-Public: (01)00802526497001(17)270421
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2026

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: 0676
• Device Catalogue Number: 0676
• Device Lot Number: 521039
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/11/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 08/27/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/23/2026; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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: 88 YR
• Patient Sex: Male