MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE/EP-4 USB KEYBOARD; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H21913

Device Problem Tactile Prompts/Feedback (4022)

Patient Problem Atrial Fibrillation (1729)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the procedure, atrial fibrillation was induced due to a loss of pacing control.The mouse pointer on both the odyssey large monitor and native claris monitor was slow to react and movement was intermittent.During normal pacing maneuvers, control of the pacing was lost.There was decrease in cl down to 100 ms.It was not possible to stop or adjust the pacing with ep-4 touch screen or the claris or odyssey mouse or keyboard controls.After several attempts the pacing was stopped.The system and touch screen were rebooted and the procedure continued.After a while the issue recurred.The system and touch screen were rebooted again and the procedure continued.Atrial fibrillation was induced.There was a spontaneous recovery to sinus rhythm and no cardioversion was needed.The procedure was completed without adverse effects to the patient.

Manufacturer Narrative

Additional information: the results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be determined.

Manufacturer Narrative

Additional information was received that the issue was caused by the keyboard and not the workmate claris system.

• Brand Name: EP-WORKMATE/EP-4 USB KEYBOARD
• 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: 9097467
• MDR Text Key: 159334928
• Report Number: 2184149-2019-00170
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (y/n): N
• PMA/PMN Number: K132073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H21913
• Device Lot Number: 5879399
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention