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

Model Number 1158T

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported to technical services on 8/3/2011, that this iv lead has diaphragmatic stimulation.And the outputs are already as low.As the md feels comfortable with.Other options were discussed with dr.(b)(6).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: 17531891
• MDR Text Key: 321452321
• Report Number: MW5138802
• 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