MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ PRECISION¿ SOFTWARE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H702496

Device Problem Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

During a pulmonary vein isolation procedure a cancellation occurred due to a system failure.The issue was not resolved and the procedure was cancelled.There were no adverse patient consequences.

Manufacturer Narrative

A review of the precision software files was performed.The review of the study did not verify that a software shutdown occurred.Based on the information available the cause for the reported system failure and subsequent cancellation could not be conclusively determined.

• Brand Name: ENSITE¿ PRECISION¿ SOFTWARE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8305472
• MDR Text Key: 135017553
• Report Number: 2184149-2019-00014
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K160210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H702496
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other