MAUDE Adverse Event Report: ST. JUDE MEDICAL EP-WORKMATE EP-4 TOUCHSCREEN COMPUTER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 09-1694-1002

Device Problem Loss of Threshold (1633)

Patient Problem Cardiac Arrest (1762)

Event Date 06/19/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis; however, field service was conducted on the device and no alleged deficiency was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformance's were identified that are related to the reported event.Based on the information received, the cause of the reported incident could not be determined.

Event Description

During an atrial fibrillation ablation procedure, the patient came in already in atrial fibrillation.The patient then went into cardiorespiratory arrest and the stimulation function of the abbott device did not function for four minutes when attempted to be used for the patient's condition.Despite several device restarts, the issue remained.A heart massage was then given as stimulation was not able to be delivered.The procedure was unable to be completed and the patient was sent to the intensive care unit for three days.

• Brand Name: EP-WORKMATE EP-4 TOUCHSCREEN COMPUTER
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12202547
• MDR Text Key: 262643882
• Report Number: 2184149-2021-00221
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09-1694-1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2009
• 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): Required Intervention