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

Model Number	H21913
Medical Device Problem Code	Tactile Prompts/Feedback (4022)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9097467
• Report Number: 2184149-2019-00170
• Device Sequence Number: 2652768
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K132073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H21913
• Device Lot Number: 5879399
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/24/2019; 12/18/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/24/2019; 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention