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

Model Number 1156T

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Sepsis (2067)

Event Type  malfunction  

Event Description

Technical services received a call on (b)(6) 2012 from sales rep.Patient is septic due to hip replacement.Pt scheduled for explant of system.Everything was working fine with device until today when device got interrogate by rep and she noticed a fault code 1003.No physician or hospital known.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: QUICKFLEX
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17529543
• MDR Text Key: 321331914
• Report Number: MW5136469
• 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: 12/21/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1156T
• Patient Sequence Number: 1