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 Skin Tears (2516)

Event Date 07/20/2020

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 was requested but not received.

Event Description

During an ablation procedure, a skin tear occurred.While being removed, the surface electrode patch tore the skin on the left upper thigh.The site of the patch was bleeding.The skin was prepped per the ifu guidelines.Bandage dressing was administered to the patient for treatment.There were no performance issues with any abbott device.

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 skin tear could not be conclusively determined.

• 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: 10408416
• MDR Text Key: 202955506
• Report Number: 3008452825-2020-00411
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067025937
• UDI-Public: 05415067025937
• Combination Product (y/n): N
• PMA/PMN Number: K183128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: EN0020-P
• Device Catalogue Number: EN0020-P
• Device Lot Number: 7455538
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other