MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CONTACT MAPPING ENSITE¿ NAVX¿ NAVIGATION AND VISUALIZATION, TECHNOLOGY, ENSITE N; COMPUTER, DIAGNOSTIC PROGRAMMABLE

Model Number EN0010

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

Patient Problem Burn(s) (1757)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.The device history record for the above-referenced product was unable to be reviewed since the batch number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During a pulmonary vein isolation procedure, a patient burn occurred.Following the successful ablation, a burn was noted on the left upper back of the patient.The burn was slightly larger than a quarter, described as round and red with a white skin tone around the burn, which was slightly deep.The burn was noted at the corner of the ensite navx patch proximal to the spine and the dispersive pad; however, no apparent patch overlap was noted.The patient's skin was not hairy or diaphoretic during the ablation procedure and no skin preparation was performed due to this.A wound specialist was consulted, unknown treatment was administered, and the patient has since been discharged.There were no performance issues with any sjm device during the procedure.

• Brand Name: CONTACT MAPPING ENSITE¿ NAVX¿ NAVIGATION AND VISUALIZATION, TECHNOLOGY, ENSITE N
• Type of Device: COMPUTER, DIAGNOSTIC PROGRAMMABLE
• 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: 5707990
• MDR Text Key: 46896891
• Report Number: 2184149-2016-00006
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 549884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2016

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: 05/12/2016
• Initial Date FDA Received: 06/08/2016
• 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
• Patient Weight: 89