MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 09-1462-0056

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2015

Event Type  Injury  

Event Description

During an electrophysiology procedure, an unnecessary shock was delivered while the patient was in sinus rhythm.The patient remained in sinus rhythm and there were no adverse consequences.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.Examination of the workmate logs returned confirmed a defibrillation shock was performed and a second one approximately 30 seconds later.The workmate logs also confirm that the system was restarted on the reported date.Review of the study indicated the patient was in normal sinus rhythm at study start.Comments in the study indicated the introduction of atrial fibrillation followed by what appear as attempts to pace out of the induced rhythm prior to the cardioversion.Based on the study provided, it appears that atrial fibrillation was still present prior to the first cardioversion returning to normal sinus rhythm after.Further, there are intermittent pacs with otherwise normal sinus rhythm prior to the second cardioversion with normal sinus rhythm after.While we are unable to confirm, it is possible that the replay action was initiated from the review screen.Selecting the replay button will replay the currently displayed review image on the real-time monitor at the current displayed speed.Signals will continue to display until the replay button is pressed again or the recording ends.Based on the information provided to st.Jude medical, the cause of the reported display delay remains unknown.

Event Description

Additional information received from the user indicates there was a delay in the display of the ekg on the recording system.The display indicated the patient was a persistent arrhythmia and a shock was delivered; however, review indicated the patient was in sinus rhythm prior to the shock.Rebooting the system resolved the display issue.

• Brand Name: EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 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; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4903206
• MDR Text Key: 6541154
• Report Number: 2184149-2015-00005
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K092810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09-1462-0056
• Device Catalogue Number: 09-1462-0056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other