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 03/04/2022

Event Type  Injury  

Event Description

During a persistent redo atrial fibrillation pulmonary vein isolation procedure, the patients skin was damaged while removing the inner left leg patch.The wound was treated with gel and xeroform gauze.The patient was reported to have thin skin.There were no performance issues noted with the patches.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis; however, one image was returned.The image appears to show a wound on the patient¿s skin.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported skin tear remains unknown.

• 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: 13932551
• MDR Text Key: 288661915
• Report Number: 3008452825-2022-00092
• 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: K202066
• 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: 03/28/2022

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 Expiration Date: 06/30/2022
• Device Model Number: ENSITE-SEK-5-01
• Device Catalogue Number: ENSITE-SEK-5-01
• Device Lot Number: 7795957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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: 83 YR
• Patient Sex: Male