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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE CLARIS EP-4 CARDIAC STIMULATOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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ST. JUDE MEDICAL WORKMATE CLARIS EP-4 CARDIAC STIMULATOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H403023
Medical Device Problem Code Communication or Transmission Problem (2896)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/12/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.
 
Event or Problem Description
During a supraventricular tachycardia ablation procedure, the ep-4 showed as "off or disconnected" on the system and the procedure was not able to be completed.The device was bypassed without the touchscreen and the issue remained.There were no adverse consequences to the patient.
 
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Brand Name
WORKMATE CLARIS EP-4 CARDIAC STIMULATOR
Common Device Name
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
MDR Report Key11359125
Report Number2184149-2021-00051
Device Sequence Number4170509
Product Code DQK
UDI-Device Identifier05414734030236
UDI-Public05414734030236
Combination Product (Y/N)N
Initial Reporter CountryID
PMA/510(K) Number
K092913
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberH403023
Device Catalogue NumberH403023
Device Lot Number6673214
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2021
Initial Report FDA Received Date02/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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