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

Model Number EN0020-P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 03/05/2019

Event Type  Injury  

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 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 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.

Manufacturer Narrative

Additional information:.

• Brand Name: ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT
• Type of Device: 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
• MDR Text Key: 166550733
• Report Number: 3008452825-2019-00560
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067025937
• UDI-Public: 05415067025937
• Combination Product (y/n): N
• PMA/PMN Number: K160210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPERE¿ RF ABLATION GENERATOR; AMPERE¿ RF ABLATION GENERATOR
• Patient Outcome(s): Other