MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number EN0020-P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 11/06/2017

Event Type  Injury  

Event Description

After an ablation procedure, a burn with a small blister was noted on the skin where the indifferent patch had been located.The patient was neither hairy or diaphoretic.The burn was treated with a dressing and a bandage.There were no performance issues with any abbott device.

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 burn could not be conclusively determined.The device history record for the above-referenced product was unable to be reviewed since the serial number is unknown.

• Brand Name: ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING 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: 7082744
• MDR Text Key: 93722716
• Report Number: 2184149-2017-00066
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160186
• 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: 01/25/2018

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: EN0020-P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 01/25/2018
• 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 Outcome(s): Other