MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	EN0020-P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.
Event or Problem Description
At the end of a procedure a skin tear occurred when the patch was removed.
Event or Problem Description
At the end of an atrial fibrillation ablation procedure a skin tear occurred.The skin was not prepped but the patch was placed on skin that was neither hairy or diaphoretic.The procedure was completed with no issues but upon removal of the pad a skin tear was noted.The skin was treated with betadine.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
One image was submitted to product performance engineering for evaluation which appeared to show a peeling skin.Based solely on the image submitted, skin appeared peeled.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided, the cause of the reported event remains unknown.

• Brand Name: ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8926520
• Report Number: 3008452825-2019-00430
• Device Sequence Number: 11269837
• Product Code: DQK
• UDI-Device Identifier: 05415067025937
• UDI-Public: 05415067025937
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 10/31/2019
• Device Model Number: EN0020-P
• Device Lot Number: 7019485
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other