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

Model Number	EN0020-P
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
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 an atrial arrhythmia procedure, the ensite patches were removed from the patient and it was noted the neck and back patches were incorrectly swapped throughout the procedure.The patient arrived to the procedure room with an arrhythmia for a redo ablation procedure.The location of the arrhythmia was found to be originating from the right atrium but below the septum.The geometry appeared somewhat distorted however, the mapping portion of the procedure was completed with this incorrect placement.The procedure was unsuccessful and there were no adverse consequences to the patient.It is unknown if the procedure will be rescheduled.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident was due to the user placing the patches on the patient in the incorrect orientation.If a user selects incorrect locations for navx patch placement, it will result in the coordinate system not being valid.An invalid coordinate system will result in displayed movement and in some cases the actual movement will be reversed.

• Brand Name: ENSITE PRECISION SURFACE ELECTRODE KIT
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); 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: 10619315
• Report Number: 3008452825-2020-00515
• Device Sequence Number: 19558569
• Product Code: DQK
• UDI-Device Identifier: 05415067025937
• UDI-Public: 05415067025937
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: EN0020-P
• Device Catalogue Number: EN0020-P
• Device Lot Number: 7579712
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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: 106