MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT?; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	0675
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead is short-circuiting causing the atrium to fire faster than the ventricles.The patient indicated that their health care professional (hcp) scheduled an ablation procedure and if that was successful that another lead would be placed.At this time, this lead remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If additional pertinent information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead is short-circuiting causing the atrium to fire faster than the ventricles.The patient indicated that their health care professional (hcp) scheduled an ablation procedure and if that was successful that another lead would be placed.At this time, this lead remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.No serial/lot number was provided; therefore a dhr review cannot be performed.If the applicable information becomes available, the investigation record will be re-opened and updated accordingly with the results of the device history record (dhr) review.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.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: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 24147636
• Report Number: 2124215-2026-04073
• Device Sequence Number: 9486748
• Product Code: NVY
• UDI-Device Identifier: 00802526496981
• UDI-Public: (01)00802526496981(17)250522
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 05/22/2025
• Device Model Number: 0675
• Device Catalogue Number: 0675
• Device Lot Number: 511942
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 05/23/2023
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male