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

Model Number 0673

Device Problems Failure to Capture (1081); Positioning Problem (3009); High Capture Threshold (3266)

Patient Problem Perforation (2001)

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that this right ventricular lead experienced perforation.Due to this the lead exhibited high pacing thresholds and loss of capture.A lead revision was performed and the lead was attempted to be repositioned twice, however the attempts were not successful.It was decided to explant the lead and another one was implanted instead.This lead is expected to be returned to boston scientific for evaluation.No further adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Visual examination noted tissue entwined at the tip.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.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 this right ventricular lead experienced perforation.Due to this the lead exhibited high pacing thresholds and loss of capture.A lead revision was performed and the lead was attempted to be repositioned twice, however the attempts were not successful.It was decided to explant the lead and another one was implanted instead.This lead is expected to be returned to boston scientific for evaluation.No further adverse patient effects were reported.

• 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: 18983735
• MDR Text Key: 338659060
• Report Number: 2124215-2024-18342
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 200414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• 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): Hospitalization; Required Intervention