MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; Drug eluting permanent left ventricular (lv) pacemaker electrode

Model Number 1258T/86

Device Problems Intermittent Capture (1080); Device Dislodged or Dislocated (2923)

Patient Problem Discomfort (2330)

Event Date 02/01/2024

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for a follow-up.Upon review, it was discovered that the left ventricular lead exhibited intermittent capture.An x-ray was performed, and it was noted that the lead had pulled back.The lead was explanted and replaced.The patient was in stable condition.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Type of Device: Drug eluting permanent left ventricular (lv) pacemaker electrode
• 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: 18744410
• MDR Text Key: 335809174
• Report Number: 2017865-2024-33130
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 1258T/86
• Device Lot Number: A000026325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2016
• 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
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 93 KG