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

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.

• Brand Name: WORKMATE CLARIS AMPLIFIER
• Type of Device: WORKMATE CLARIS AMPLIFIER
• Manufacturer (Section D): ST. JUDE MEDICAL; st. paul MN 55117
• MDR Report Key: 5966174
• MDR Text Key: 55684383
• Report Number: MW5064890
• Device Sequence Number: 1
• Product Code: DQK
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Weight: 43