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

Model Number 1056T

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Early battery depletion.Lv outputs programmed at 3.25v@1.5ms.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: QUICKSITE
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.
• MDR Report Key: 17524669
• MDR Text Key: 321314844
• Report Number: MW5131615
• 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: 09/01/2022

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: 1056T
• Patient Sequence Number: 1