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

Model Number	0663
Medical Device Problem Codes	High impedance (1291); Pacing Problem (1439); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that right ventricular (rv) defibrillation lead exhibited a gradual rise in pace impedance measurements from mid-400 ohms range to greater than 2,000 ohms since (b)(6) 2024.Rv threshold had also increased from less than 1v to approximately 1.5v.There was no evidence of noise in stored episodes.Sensing was stable, however there was no pacing at all.When asked about changes in medical history around late (b)(6) 2024, and it was noted that the patient had been hospitalized for coronary artery disease.Technical servicees (ts) discussed that changes in patient condition can impact lead measurements and may be indicative of lead calcification.Ts also reviewed troubleshooting/programming considerations.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.Impact code updated from f10:inadequate/inappropriate treatment or diagnostic exposure to f1001:absence of treatment.
Event or Problem Description
It was reported that right ventricular (rv) defibrillation lead exhibited a gradual rise in pace impedance measurements from mid-400 ohms range to greater than 2,000 ohms since september 2024.Rv threshold had also increased from less than 1v to approximately 1.5v.There was no evidence of noise in stored episodes.Sensing was stable, however there was no pacing at all.When asked about changes in medical history around late september 2024, and it was noted that the patient had been hospitalized for coronary artery disease.Technical servicees (ts) discussed that changes in patient condition can impact lead measurements and may be indicative of lead calcification.Ts also reviewed troubleshooting/programming considerations.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.Correction to h6: impact code updated from f10: inadequate/inappropriate treatment or diagnostic exposure to f1001: absence of treatment.
Event or Problem Description
It was reported that right ventricular (rv) defibrillation lead exhibited a gradual rise in pace impedance measurements from mid-400 ohms range to greater than 2,000 ohms since (b)(6) 2024.Rv threshold had also increased from less than 1v to approximately 1.5v.There was no evidence of noise in stored episodes.Sensing was stable, however there was no pacing at all.When asked about changes in medical history around late (b)(6) 2024, and it was noted that the patient had been hospitalized for coronary artery disease.Technical servicees (ts) discussed that changes in patient condition can impact lead measurements and may be indicative of lead calcification.Ts also reviewed troubleshooting/programming considerations.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that this rv lead continued to exhibit gradually increasing pace impedance measurements greater than 3,000 ohms and elevated threshold measurements.Intrinsic amplitudes were within normal limits and unaffected by the rise in lead measurements.Technical services (ts) discussed possible causes and next steps, such as potential lead revision.The patient was seen in clinic, and this rv lead remains in service.No adverse patient effects or interventions were reported at this time.

• 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: 21893834
• Report Number: 2124215-2025-25860
• Device Sequence Number: 19715494
• Product Code: NVY
• UDI-Device Identifier: 00802526592805
• UDI-Public: (01)00802526592805(17)230209
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 09/03/2025

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: 02/09/2023
• Device Model Number: 0663
• Device Catalogue Number: 0663
• Device Lot Number: 136322
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 08/04/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 04/25/2025; 09/03/2025
• Date Device Manufactured: 02/09/2021
• 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: 80 YR
• Patient Sex: Male