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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. EP-WORKMATE/EP-4 USB KEYBOARD COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameEP-WORKMATE/EP-4 USB KEYBOARD
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key9097467
MDR Text Key159334928
Report Number2184149-2019-00170
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K132073
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH21913
Device Lot Number5879399
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/20/2019 Patient Sequence Number: 1
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