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

Model Number 1158T

Device Problem Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This l v lead was implanted on (b)(6) 2011.A call to technical services on 8/25/11 states that the lv lead impedance was 1303 on report.Had been 814-1200's.Caller will call st.Jude medical to find out acceptable lead impedance range for this lead.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: QUICKFLEX XL
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17529643
• MDR Text Key: 321252646
• Report Number: MW5136568
• 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: 09/01/2011

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: 1158T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1