MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA 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 Skin Tears (2516)

Event Date 08/21/2019

Event Type  Injury  

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 Description

At the end of a procedure a skin tear occurred when the patch was removed.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 155409275
• Report Number: 3008452825-2019-00430
• 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: 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
• Device Operator: 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 Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other