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

Model Number 0672

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problems Chest Pain (1776); Cardiac Perforation (2513)

Event Date 04/14/2024

Event Type  Injury  

Event Description

It was reported that two days after implant of the implantable cardioverter defibrillator (icd) system the patient experienced pain in the heart area.The patient returned to the emergency department and review of the icd data demonstrated right ventricular loss of capture at 3.5 v at 0.4 ms.Another device check was performed on april 16 which demonstrated loc at 4 v at 0.5 ms and the patient felt pain during the threshold test.A subsequent chest x-ray showed rv lead dislodgement.The patient was admitted to the hospital for rv lead revision and echocardiography and computed tomography revealed a cardiac perforation.The rv lead was successfully replaced and is expected to be returned for analysis.It was noted that the patient remained hemodynamically stable during the procedure and a pericardiocentesis was not needed.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: 19172623
• MDR Text Key: 340920552
• Report Number: 2124215-2024-24804
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: SN
• 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
• Report Date: 04/24/2024

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: Health Professional
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 221890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Male