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

Model Number	0665
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right atrial (ra) lead delivered an anti-tachycardia pacing (atp) therapy, health care professional (hcp) believed it was due to t-wave oversensing (twos).The patient has a left ventricular assist device (lvad).Technical services (ts) reviewed the episode and determined that the therapy did not appear to be caused by twos.Instead, the inappropriate atp may have resulted from oversensing of the lvad pump signals, with no evidence of a true ventricular arrhythmia.Ts discussed the possibility that the oversensing could be positional.Health care professional (hcp) will follow up with physician.The lead remains in service, and no adverse patient effects have been reported.

• 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: 22852332
• Report Number: 2124215-2025-58276
• Device Sequence Number: 4419545
• Product Code: NVY
• UDI-Device Identifier: 00802526496967
• UDI-Public: (01)00802526496967(17)250226
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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: 02/26/2025
• Device Model Number: 0665
• Device Catalogue Number: 0665
• Device Lot Number: 511590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/20/2025
• Date Device Manufactured: 02/26/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Female