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

Model Number	0663
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
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 exhibited a gradual rise in pace impedance measurements from the mid-500 ohms ranges to greater than 2,000 ohms, with a recent measurement of 2,244 ohms.It was noted that this change was likely indicative of a physiologic cause.Shock impedance measurements were stable in the 70 ohms range.R-wave amplitude was greater than 14 mv and and the threshold was 0.8v @ 0.4 ms.Health care professional (hcp) performed lead testing with isometrics, but there was no evidence of noise or high out-of-range pace impedance measurements greater than 3,000 ohms.Technical services (ts) discussed troubleshooting options and programming considerations.This rv lead remains in service.No adverse patient effects were 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: 20477352
• Report Number: 2124215-2024-65174
• Device Sequence Number: 8267124
• Product Code: NVY
• UDI-Device Identifier: 00802526592805
• UDI-Public: 00802526592805
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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: 05/03/2024
• Device Model Number: 0663
• Device Catalogue Number: 0663
• Device Lot Number: 170040
• 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: 09/25/2024
• Initial Report FDA Received Date: 10/17/2024
• Date Device Manufactured: 05/03/2022
• 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: 78 YR
• Patient Sex: Male