MAUDE Adverse Event Report: ST. JUDE UNIFY ASSURA ICD

Model Number 3357-40Q

Device Problems Device Remains Activated (1525); Inappropriate/Inadequate Shock/Stimulation (1574); Inaudible or Unclear Audible Prompt/Feedback (2283)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/03/2016

Event Type  malfunction  

Event Description

It was described that a magnet was placed over the icd to activate it but it did not deactivate and the patient continued to be shocked during surgery.The rep came in and stated the magnet needed to be offset which has never been described to medical staff before.Additionally, this icd does not issue an audible sound when deactivated so it is impossible to determine if deactivation has occurred.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: UNIFY ASSURA ICD
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 5491661
• MDR Text Key: 40126637
• Report Number: MW5060818
• Device Sequence Number: 1
• Product Code: NIK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3357-40Q
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1