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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H403023
Device Problem Device Remains Activated (1525)
Patient Problem Atrial Fibrillation (1729)
Event Type  Injury  
Manufacturer Narrative
Concomitant device: workmate¿ claris¿ system computer. The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.  .
 
Event Description
(b)(4). 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¿ EP-4¿ CARDIAC STIMULATOR
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 Key9432652
MDR Text Key169713432
Report Number2184149-2019-00246
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K092913
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 NumberH403023
Device Lot Number5067210
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
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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