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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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)
• Common Device Name: 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
• Report Number: 3008452825-2022-00092
• Device Sequence Number: 14453940
• Product Code: DQK
• UDI-Device Identifier: 05415067032379
• UDI-Public: 05415067032379
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male