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

Model Number	0636
Medical Device Problem Codes	Insufficient Device Problem Information (3190); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this right ventricular (rv) lead was surgically abandoned due to an unknown reason.A new rv lead was successfully placed on the rv septum.This rv lead is not expected to be returned.Additional information is being requested from the field.No additional adverse patient effects.
Additional Manufacturer Narrative
This product was surgically abandoned and was not returned.As such, physical analysis has not been conducted in our laboratory.Based on the available information, and in the absence of a product return, no problem was detected.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that that this right ventricular (rv) lead was surgically abandoned due to an unknown reason.A new rv lead was successfully placed on the rv septum.This rv lead is not expected to be returned.Additional information is being requested from the field.No additional adverse patient effects.Additional information confirmed that this rv lead was exhibiting high capture thresholds and indicated that the procedure was successfully completed without any complications.

• 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: 24461306
• Report Number: 2124215-2026-10840
• Device Sequence Number: 15965510
• Product Code: NVY
• UDI-Device Identifier: 00802526496868
• UDI-Public: (01)00802526496868(17)260411
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 04/11/2026
• Device Model Number: 0636
• Device Catalogue Number: 0636
• Device Lot Number: 517555
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 04/11/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male