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

Model Number 0672

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

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

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) threshold had been rising since implant of the implantable cardioverter defibrillator system.In (b)(6) 2023 threshold was 1.7 v and in (b)(6) 2024, at the time the patient underwent valve surgery, it was 2.7 v.The patient attended a follow-up appointment in (b)(6) 2024 at which time it was noted that a presenting electrogram demonstrated rv loss of capture and that the patient had been in atrial fibrillation since the valve surgery.The rv output was increased.An upcoming cardioversion was planned, and the patient was to discuss the possibility of rv lead replacement at a subsequent follow-up.The rv lead remains in service.

Event Description

It was reported that the right ventricular (rv) threshold had been rising since implant of the implantable cardioverter defibrillator system.In (b)(6) 2023 threshold was 1.7 v and in (b)(6) 2024, at the time the patient underwent valve surgery, it was 2.7 v.The patient attended a follow-up appointment in (b)(6) 2024 at which time it was noted that a presenting electrogram demonstrated rv loss of capture and that the patient had been in atrial fibrillation since the valve surgery.The rv output was increased.An upcoming cardioversion was planned, and the patient was to discuss the possibility of rv lead replacement at a subsequent follow-up.The rv lead remains in service.Additional information received indicated that the rv lead was explanted and replaced.No additional adverse patient effects were reported.The lead was received for analysis.

• 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: 18817935
• MDR Text Key: 337619574
• Report Number: 2124215-2024-12599
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 200409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2022
• 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): Hospitalization; Required Intervention