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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE CLARIS AMPLIFIER

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ST. JUDE MEDICAL WORKMATE CLARIS AMPLIFIER Back to Search Results
Device Problems Break (1069); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2016
Event Type  malfunction  
Event Description
Patient was scheduled for an electrophysiology study of the conduction system of his heart. Placed under general anesthesia and the procedure begun. Introducer sheaths placed into his right femoral vein and the monitoring/stimulating catheters were placed. When we tried to stimulate the heart using st. Jude stimulator, we did not get communication between the monitor and the stimulator. We performed trouble shooting maneuvers without success. Calls placed to st. Jude support services dept and to the clinical specialist with st. Jude medical. Another clinical support staff member from st. Jude medical was present in the procedure. The problem was narrowed down to the daisy chain connecting cable. St. Jude rep borrowed another cable and drove to pick it up. With the borrowed cable still did not have communication. Upon further investigation we determined the receiving port of the cable was broken. Stimulator was part of the ep equipment upgrade in 08/2016 and is under warranty. Aborted the procedure until such time that we have working equipment. Patient had been under anesthesia 3 hours during the trouble shooting. Family advised of the need to abort the procedure and reschedule when the equipment was properly working.
 
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Brand NameWORKMATE CLARIS AMPLIFIER
Type of DeviceWORKMATE CLARIS AMPLIFIER
Manufacturer (Section D)
ST. JUDE MEDICAL
st. paul MN 55117
MDR Report Key5966174
MDR Text Key55684383
Report NumberMW5064890
Device Sequence Number1
Product Code DQK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/19/2016 Patient Sequence Number: 1
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