MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number LDA210Q/65

Device Problem Failure to Sense (1559)

Patient Problems Discomfort (2330); Cardiac Perforation (2513)

Event Date 05/23/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department with chest pain.Upon review, the right ventricular lead was not sensing cardiac arrhythmias.A computerized tomography showed that the right ventricular lead had perforated the ventricle wall.The lead was repositioned successfully on (b)(6) 2022.The patient condition was stable.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16920273
• MDR Text Key: 315105630
• Report Number: 2017865-2023-19823
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: 05414734507332
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2023

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 Expiration Date: 04/30/2024
• Device Model Number: LDA210Q/65
• Device Catalogue Number: LDA210Q-65
• Device Lot Number: A000110312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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): Other; Required Intervention