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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H700150
Device Problem Failure to Analyze Signal (1539)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
During an atrial fibrillation ablation procedure, a cancellation occurred due to intracardiac signal loss. Troubleshooting consisted of bypassing cardo, power cycling, swapping the ecg cables, checking the connection between the stimulator and amplifier, repositioning the right lead, exchanging the right leg lead patch and resetting the notch filter but the issue remained. The procedure was cancelled and there were no adverse patient consequences.
 
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Brand NameWORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER
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 Key9491397
MDR Text Key176838523
Report Number2184149-2019-00251
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH700150
Device Catalogue NumberH700124
Device Lot Number6018016
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 Received01/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2019
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: 12/18/2019 Patient Sequence Number: 1
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