MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US); COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SEK-5-01

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

Patient Problem Skin Tears (2516)

Event Date 10/16/2023

Event Type  Injury  

Event Description

During an atrial fibrillation procedure, the patches were very sticky and the patient's skin minorly teared under the left armpit upon removal.The area had been prepped for patch placement including shaving hairy areas.No treatment was necessary for the skin tear and there were no alleged performance issues with the patches.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported skin tear could not be conclusively determined.

• Brand Name: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US)
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18057718
• MDR Text Key: 327195064
• Report Number: 3008452825-2023-00506
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067032379
• UDI-Public: 05415067032379
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231415
• 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,Followup
• Report Date: 11/20/2023

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: ENSITE-SEK-5-01
• Device Lot Number: 9086950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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