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	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Following atrial fibrillation ablation, the patients skin was torn when removing the blue patch from the patients leg.The damage was localized on the left knee.
Additional Manufacturer Narrative
Two images were submitted to product performance engineering.The images appear to show a patient skin tear on the leg.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported skin tear could not be conclusively determined.

• 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: 9483157
• Report Number: 3008452825-2019-00635
• Device Sequence Number: 16234658
• Product Code: DQK
• UDI-Device Identifier: 05415067025937
• UDI-Public: 05415067025937
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183128
• 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): 01/09/2020

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: No Information
• Device Expiration Date: 03/31/2020
• Device Model Number: EN0020-P
• Device Catalogue Number: EN0020-P
• Device Lot Number: 7233472
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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
• Patient Age: 76 YR
• Patient Weight: 65