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

Model Number 0672

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problems Cardiac Arrest (1762); Cardiac Perforation (2513)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this patient experienced cardiac arrest while on vacation in late january.Since then, the clinic observed a consistent increase in right ventricular (rv) lead thresholds to the point that there was no capture at maximum outputs.An echocardiogram was performed, and it was determined that the lead tip had perforated the ventricular wall and into the pericardial space.As a result, this rv lead was explanted and replaced.It was noted that the device was also explanted and replaced during the rv lead revision.No additional adverse patient effects were reported.This rv lead is expected to be returned for analysis.

Event Description

It was reported that this patient experienced cardiac arrest while on vacation in late january.Since then, the clinic observed a consistent increase in right ventricular (rv) lead thresholds to the point that there was no capture at maximum outputs.An echocardiogram was performed, and it was determined that the lead tip had perforated the ventricular wall and into the pericardial space.As a result, this rv lead was explanted and replaced.It was noted that the device was also explanted and replaced during the rv lead revision.No additional adverse patient effects were reported.This rv lead is expected to be returned for analysis.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The related investigation determined that this lead was associated with a reported perforation with no conclusive evidence of a malfunction; please refer to the description b5 field for more information regarding the specific circumstances of this event.

Event Description

It was reported that this patient experienced cardiac arrest while on vacation in late (b)(6).Since then, the clinic observed a consistent increase in right ventricular (rv) lead thresholds to the point that there was no capture at maximum outputs.An echocardiogram was performed, and it was determined that the lead tip had perforated the ventricular wall and into the pericardial space.As a result, this rv lead was explanted and replaced.It was noted that the device was also explanted and replaced during the rv lead revision.No additional adverse patient effects were reported.This rv lead is expected to be returned for analysis.

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 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.The related investigation determined that this lead was associated with a reported perforation and laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.Please refer to the description for more information regarding the specific circumstances of this event.

• 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: 16616711
• MDR Text Key: 312005810
• Report Number: 2124215-2023-14099
• Device Sequence Number: 1
• Product Code: LWS
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 206474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• 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 Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female