MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US); ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number ENSITE-SEK-5-01

Device Problem Failure to Disconnect (2541)

Patient Problem Skin Tears (2516)

Event Date 09/22/2022

Event Type  Injury  

Event Description

Following a premature ventricular contraction procedure, a skin tear occurred.When the patches were being removed after the procedure, groin pressure was held with one hand, and the other hand reached under the patient¿s blanket and ripped off the ground pad.The skin tore and was bruised in the area where the ground pad was located.The patient was bandaged and immediately taken care of.

Manufacturer Narrative

Images were submitted for evaluation to product performance engineering; no device components were returned.The photos appeared to show a wound on a patient caused by patch removal.Visual inspection was based solely upon a review of the photographs provided.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: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• 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: 15524176
• MDR Text Key: 300999921
• Report Number: 3008452825-2022-00625
• 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: K083328
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: ENSITE-SEK-5-01
• Device Catalogue Number: ENSITE-SEK-5-01
• Device Lot Number: 8624128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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: 85 YR
• Patient Sex: Female
• Patient Weight: 67 KG