MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-ST. PAUL) NAVX SURFACE ELECTRODE KIT

Model Number EN0010

Device Problem Arcing (2583)

Patient Problem Burn(s) (1757)

Event Date 03/05/2014

Event Type  Injury  

Event Description

During an atrial flutter ablation procedure using ensite navx surface patches, the patient experienced a burn.During ablation, the patient was in atrial fibrillation and a cardioversion was performed.The physician moved the defibrillation patch from its original position to an area where it was in contact with the corner of the ensite navx chest patch.When 360 joules were delivered during cardioversion, an electrical arc was noted, which created a burn on the surface of the patient's skin where the corner of the chest patch and the defibrillation patch contacted one another.The defibrillation patch was then moved and the patient was successfully converted to sinus rhythm.The patient reverted back to atrial fibrillation and the case was cancelled as the ep lab was not set up to do an atrial fibrillation ablation.A cream was applied to the superficial burn.The patient remained stable throughout.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the receiving and inspection records was not possible since the lot was unavailable.Based on the info rec'd, the cause of the reported patient burn was procedure related.The ensite instructions for use states ensure that surface electrodes and associated connectors do not contact one another, electrical ground, or metallic objects.'.

• Brand Name: NAVX SURFACE ELECTRODE KIT
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); st. paul MN
• Manufacturer Contact: denise johnson, rn ; 177 east country road b; st. paul, MN 55117 ; 6517564071
• MDR Report Key: 3732919
• MDR Text Key: 4325073
• Report Number: 2184149-2014-00002
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2014

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: EN0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR