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 Tissue Damage (2104)

Event Date 03/02/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the inspection results for this lot number confirmed that no nonconformances were identified related to the reported event and the product met sjm specifications.Based on the information received, the cause of the reported abrasion could not be conclusively determined.

Event Description

During an atrial fibrillation case, a patient abrasion occurred.The surface electrodes of the precision were removed and the skin was reddened with tiny blisters.The patient's skin was not prepped.The ablation procedure lasted five hours.A burn ointment was applied to treat the patient.There were no performance issues with any sjm device during the procedure.

• 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: 6449842
• MDR Text Key: 71394000
• Report Number: 2184149-2017-00002
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: EN0020-P
• Device Lot Number: 5713578
• Other Device ID Number: 05415067025937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• 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
• Patient Age: 53 YR
• Patient Weight: 90