MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0692

Device Problems Failure to Capture (1081); Failure to Sense (1559)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

This product has been returned back from the field for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that during an implant procedure, this right ventricular (rv) lead did not exhibit any sensing or capture values in multiple positions.The rv lead was removed and replaced prior to pocket closure and was never in service.No adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that during an implant procedure, this right ventricular (rv) lead did not exhibit any sensing or capture values in multiple positions.The rv lead was removed and replaced prior to pocket closure and was never in service.No adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11233769
• MDR Text Key: 228844251
• Report Number: 2124215-2020-29153
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2022
• Device Model Number: 0692
• Device Catalogue Number: 0692
• Device Lot Number: 559768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 04/07/2021
• Patient Sequence Number: 1
• Patient Age: 75 YR