MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; PERMANENT DEFIBRILLATION ELECTRODE

Model Number 0673

Device Problem Failure to Convert Rhythm (1540)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported that this single chamber implantable cardioverter defibrillator (icd) and associated right ventricular (rv) lead were implanted.During defibrillation threshold (dft) testing, the patient was induced but the delivered shocks did not convert the ventricular fibrillation (vf) and external shocks were required.During the first induction, the lead was located mid-septal, and a 21 joule, 31 j, and 41 j shock all failed to convert.Shock impedances were normal, at 62-64 ohms.The rhythm was converted with an external shock and the lead was repositioned to an apical location.During the second induction, two 41 joule shocks failed to convert and another external shock was delivered.A third induction was tried where one 41 joule shock was delivered and failed so another external shock was needed.At this point, the physician explanted and boston scientific lead and device and implanted a competitor's system, where the first induction was successfully converted with a 35 joule shock.Technical services discussed there could be many contributing factors, such as lead position, the number of inductions, and the length of procedure/sedation.The sales representative noted local anesthesia is used for implant procedure and propofol (an anesthetic and a sedative) for the dft testing.No adverse patient effects were reported.The explanted device and lead were expected to be returned for analysis.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

It was reported that this single chamber implantable cardioverter defibrillator (icd) and associated right ventricular (rv) lead were implanted.During defibrillation threshold (dft) testing, the patient was induced but the delivered shocks did not convert the ventricular fibrillation (vf) and external shocks were required.During the first induction, the lead was located mid-septal, and a 21 joule, 31 j, and 41 j shock all failed to convert.Shock impedances were normal, at 62-64 ohms.The rhythm was converted with an external shock and the lead was repositioned to an apical location.During the second induction, two 41 joule shocks failed to convert and another external shock was delivered.A third induction was tried where one 41 joule shock was delivered and failed so another external shock was needed.At this point, the physician explanted the boston scientific lead and device and implanted a competitor's system, where the first induction was successfully converted with a 35 joule shock.Technical services discussed there could be many contributing factors, such as lead position, the number of inductions, and the length of procedure/sedation.The sales representative noted local anesthesia is used for implant procedure and propofol (an anesthetic and a sedative) for the dft testing.No adverse patient effects were reported.The explanted device and lead were returned for analysis.Reference report number (b)(4) for the associated device.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.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 confirmed setscrew marks from the device were in the correct location on the terminal pin, indicating the lead was fully inserted into the device header.Inspection of the 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 difficulties converting the induced arrhythmias during defibrillation threshold (dft) testing at the implant procedure.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: PERMANENT DEFIBRILLATION ELECTRODE
• 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: 16795733
• MDR Text Key: 313828444
• Report Number: 2124215-2023-19435
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 175450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male