MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 09-1527-0000

Device Problems Pacing Problem (1439); Communication or Transmission Problem (2896)

Patient Problem Cardiac Arrest (1762)

Event Date 05/18/2018

Event Type  Injury  

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 conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.

Event Description

During the procedure, an intracardiac defibrillation was applied using non-abbott catheter for the treatment of atrial fibrillation but would not synchronize to the body surface ecg.The defibrillation was applied at the t-wave and the patient developed ventricular fibrillation.When the body surface defibrillation was applied, the patient went into cardiac arrest.Furthermore, no pacing could be applied when attempting with the ep-4 stimulator.After six seconds of cardiac arrest, a sinus rhythm was confirmed.The pacing was attempted again but the issue remained.When the ep-workmate system was power cycled several times, the ep-4 stimulator displayed a "not connected" error.Then the ep-4 stimulator was power cycled as well which did not resolve the issue.Therefore, a non-abbott stimulator was used and the procedure was successfully completed with no adverse consequences to the patient.

• Brand Name: EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL
• 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.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7644960
• MDR Text Key: 112549101
• Report Number: 2184149-2018-00099
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151911
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09-1527-0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2012
• 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
• Treatment: BEEAT CATHETER
• Patient Outcome(s): Other