MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ DISPLAY PLUS WITHOUT EP-4; CARDIAC CATHETERIZATION MONITORING SYSTEM

Model Number H701703

Device Problem Signal Artifact/Noise (1036)

Patient Problem Cardiac Arrest (1762)

Event Date 01/16/2018

Event Type  Injury  

Event Description

During an atrial fibrillation ablation procedure the patient went into cardiac arrest.Noise was noted on the claris system, which resulted in the non-abbott stimulator not being able to apply pacing due to oversensing.The patient went into cardiac arrest but eventually stabilized with no intervention required and the procedure was completed.

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.A review of the device history record was not possible since the system serial number was provided and the component serial number was not.

Event Description

During an atrial fibrillation ablation procedure, when the claris system was connected to the non-abbott stimulator there was noise on the system.Due to the over sensing of the noise, pacing could not be applied when the patient went into cardiac arrest, resulting in the patient being asystolic for 4.3 seconds.The patient stabilized with no intervention and the procedure was completed.

• Brand Name: WORKMATE¿ CLARIS¿ DISPLAY PLUS WITHOUT EP-4
• Type of Device: CARDIAC CATHETERIZATION MONITORING SYSTEM
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7259740
• MDR Text Key: 99587173
• Report Number: 2184149-2018-00024
• Device Sequence Number: 1
• Product Code: DQK
• 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,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H701703
• Device Lot Number: 5901981
• Other Device ID Number: 05415067017031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• 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