MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC EP-WORKMATE¿ COMPUTER (HP Z600); PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 100070332

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

Based on the information received, the cause of the reported arrhythmia was user related.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Further information provided suggested the event occurred due to the settings being incorrectly chosen during the procedure.The sync check box was selected in the user settings, when it was thought to be unselected.According to the ifu the system was not able to pace because "with the sync function on, each stimulus will be produced after a trigger is detected".

Event Description

During a procedure, ventricular pacing was not delivered following adenosine administration.An error message was displayed on the windows "no sense interval - turn sync off".The sync was already turned off and pacing was not able to be completed.After 30 second of asystole and attempting to pace, the windows error was closed and pacing continued.The procedure was completed and the patient was stable.It was indicated the event was user error and there were no performance issues with any abbott device.

• Brand Name: EP-WORKMATE¿ COMPUTER (HP Z600)
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7457474
• MDR Text Key: 106390104
• Report Number: 2184149-2018-00050
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100070332
• Device Lot Number: 5492337
• Other Device ID Number: 05415067000965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other