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

Model Number 0673

Device Problems Difficult to Remove (1528); High Capture Threshold (3266)

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

Event Date 05/15/2023

Event Type  Injury  

Event Description

It was reported that during routine follow-up of the device system, high right ventricular (rv) capture thresholds were observed.The rv lead was explanted and replaced.It was stated that there was some difficulty removing the lead during explant; however, the entire device was successfully removed.The lead is expected to be 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.Visual inspection showed that the lead insulation was bunched, and the conductor coils were deformed approximately 320 mm from the terminal end.This is consistent with friction force when the lead was placed through a constricted area during removal.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.A stylet insertion test was also performed and indicated no blockage in the lead lumen.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observation of high capture threshold; however, the observation of the bunched lead insulation and deformed conductor coils was consistent with the lead placed through a constricted area.

Event Description

It was reported that during routine follow-up of the device system, high right ventricular (rv) capture thresholds were observed.The rv lead was explanted and replaced.It was stated that there was some difficulty removing the lead during explant; however, the entire device was successfully removed.The lead was returned for analysis.No additional 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 ; * 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16945925
• MDR Text Key: 315379586
• Report Number: 2124215-2023-24527
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2023
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 156847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male