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

Model Number 0673

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)

Patient Problems Presyncope (4410); Asystole (4442)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

It was reported that this patient felt faint.Technical services (ts) reviewed device episode data of the patient's cardiac resynchronization therapy defibrillator (crt-d) and found that there was noise on this right ventricular (rv) lead and shock channels and oversensing that resulted in asystole of two seconds and five seconds.This patient is dependent on pacing.In clinic, isometric testing was performed, and the noise was reproduced.An x-ray was performed.It was noted that the was a spike of rv impedance prior to stored episode of noise.Ts discussed reprogramming options and recommended testing of rv lead and revision of ra lead.No additional adverse patient effects were reported.Currently, this crt-d system remains in service.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: 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: 16435844
• MDR Text Key: 310163137
• Report Number: 2124215-2023-08700
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592867
• UDI-Public: 00802526592867
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 182690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male