MAUDE Adverse Event Report: ST. JUDE MEDICAL QUICKFLEX LEFT HEART LEADS; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 1258T

Device Problem Use of Device Problem (1670)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

It was reported that the patient with this left ventricular (lv) lead experienced bacterial infection.No additional adverse patient effects reported.This lv lead was explanted.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: QUICKFLEX LEFT HEART LEADS
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17529876
• MDR Text Key: 321130347
• Report Number: MW5136799
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1258T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1