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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ SYSTEM COMPUTER Z620 COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ SYSTEM COMPUTER Z620 COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H700977
Device Problem Device Remains Activated (1525)
Patient Problem Atrial Fibrillation (1729)
Event Type  Injury  
Manufacturer Narrative
Concomitant device: workmate ep4 cardiac stimulator. The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.  .
 
Event Description
Related manufacturing ref: 2184149-2019-00246. During the procedure, the stimulator provided an extra stimulus inducing atrial fibrillation. Cardioversion was required to stabilize the patient. The procedure was completed successfully.
 
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Brand NameWORKMATE¿ CLARIS¿ SYSTEM COMPUTER Z620
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 Key9432419
MDR Text Key169730778
Report Number2184149-2019-00245
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K151911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH700977
Device Catalogue NumberH700977
Device Lot Number5067153
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 Received12/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/06/2019 Patient Sequence Number: 1
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