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

Model Number 0672

Device Problems Failure to Capture (1081); Pacing Problem (1439); Pocket Stimulation (1463); Low impedance (2285)

Patient Problem Perforation (2001)

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

This lead will be returned for analysis.Upon return and analysis completion this investigation will be updated.

Event Description

It was reported that two days post implant the patient complained of phrenic nerve stimulation.When the device was interrogated it was noted that this right ventricular (rv) lead was not pacing, loss of capture was noted, and low pace impedance measurements were seen.Under fluoroscopy it was evident that the rv lead had perforated the right ventricular wall.This lead was thus explanted and a new lead was implanted.This lead will be returned for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that two days post implant the patient complained of phrenic nerve stimulation.When the device was interrogated it was noted that this right ventricular (rv) lead was not pacing, loss of capture was noted, and low pace impedance measurements were seen.Under fluoroscopy it was evident that the rv lead had perforated the right ventricular wall.This lead was thus explanted and a new lead was implanted.This lead was returned for analysis.No additional 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.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies other than induced damage from normal use.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.

• 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
• 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: 13228032
• MDR Text Key: 283621300
• Report Number: 2124215-2021-37315
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2023
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 164575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Female