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

Model Number	0636
Medical Device Problem Codes	Over-Sensing (1438); Off-Label Use (1494); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high pacing thresholds.Technical services (ts) reviewed electrogram (egm) data from past events and observed distinct morphologies on the rate sense channels, depending on whether the left ventricular (lv) or rv was active.The facility plans to bring the patient in for further evaluation.No adverse patient effects were reported.This rv lead remains in service.Additional information was received that the health care professional (hcp) called for assistance with programming this lv lead into magnetic resonance imaging (mri) protection mode.Technical services (ts) informed this is a non-conditional system and programmed the device.After the mri was performed, this system was removed from the mri protection mode, it was confirmed that all measurements were within normal limits and was functioning as intended.This rv lead remains in service.Additional information was received that this device exhibited t-wave oversensing.Ts provided reprogramming to avoid the issue in the future.No adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
Follow up report 1 (device evaluation): the complaint device was not returned to boston scientific; therefore, product analysis could not be performed.Conclusion code was updated to no problem detected was selected based on lack of objective evidence of a device defect/malfunction and passing product record reviews.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.It can be concluded that unknown factors most probably contributed to the event.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high pacing thresholds.Technical services (ts) reviewed electrogram (egm) data from past events and observed distinct morphologies on the rate sense channels, depending on whether the left ventricular (lv) or rv was active.The facility plans to bring the patient in for further evaluation.No adverse patient effects were reported.This rv lead remains in service.Additional information was received that the health care professional (hcp) called for assistance with programming this lv lead into magnetic resonance imaging (mri) protection mode.Technical services (ts) informed this is a non-conditional system and programmed the device.After the mri was performed, this system was removed from the mri protection mode, it was confirmed that all measurements were within normal limits and was functioning as intended.This rv lead remains in service.Additional information was received that this device exhibited t-wave oversensing.Ts provided reprogramming to avoid the issue in the future.No adverse patient effects were reported.This rv lead remains in service.

• 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: 23804538
• Report Number: 2124215-2025-90864
• Device Sequence Number: 7686599
• Product Code: NVY
• UDI-Device Identifier: 00802526496868
• UDI-Public: 00802526496868
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/17/2026
• Device Model Number: 0636
• Device Catalogue Number: 0636
• Device Lot Number: 516154
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 01/18/2024
• 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
• Patient Age: 75 YR
• Patient Sex: Male