MAUDE Adverse Event Report: ST. JUDE MEDICAL 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	Burn(s) (1757)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 burn could not be conclusively determined.Further information regarding the event were requested but not received.
Event or Problem Description
Related manufacturer reference: 2184149-2019-00219.A few weeks post procedure, reddening of the skin was noted in the region where the rf patch was positioned on the back of the patient.During procedure the radiofrequency was applied up to 40w maximum.The patient was stable.
Event or Problem Description
The patch was placed on the low back.The grounding pad did not overlap any other patches.It is unknown if there were any wrinkles or edges that were lifted on the patch.The burn was categorized as third degree.Bandages were administered to treat the burn.Currently, the burn is healed however it will scar.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
Additional information:.

• Brand Name: ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT
• 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
• MDR Report Key: 9328200
• Report Number: 3008452825-2019-00560
• Device Sequence Number: 1873285
• 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): 11/23/2019

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: 06/30/2019
• Device Model Number: EN0020-P
• Device Lot Number: 6798957
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 11/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPERE¿ RF ABLATION GENERATOR; AMPERE¿ RF ABLATION GENERATOR
• Outcome Attributed to Adverse Event: Other