MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM AMPLIFIER & DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100012713

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  Injury  

Event Description

During the ablation procedure, there was no communication on the ensite, and a yellow light was displayed.The case was not able to be completed.

Manufacturer Narrative

One ensite¿ velocity¿ cardiac mapping system pn 100015555 and sn (b)(4) was received into the lab for analysis.No accessories or original packaging was available for inspection.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.Power was applied to the returned amplifier successfully completed the post (power on self-test) and the system status light changed to green.System log files were reviewed which indicated bios and impedance out of sync at the slot 13 location on the reported event date.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported cancelled procedure could not be conclusively determined.

• Brand Name: ENSITE VELOCITY¿ SYSTEM AMPLIFIER & DISPLAY WORKSTATION
• 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: 9161716
• MDR Text Key: 161801623
• Report Number: 2184149-2019-00179
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100012713
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR