MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE PRECISION SURF ELECTRODE KIT, JP; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number PRCN-SEK-JP

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Rash (2033); Skin Tears (2516)

Event Date 06/02/2021

Event Type  Injury  

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 could not be conclusively determined. .

Event Description

During device preparation for an atrial fibrillation and atrial tachycardia procedure, when the patches were removed to correct the attachment position, a skin damage and a small amount of bleeding was noted.Additionally, there was a rash that began to develop at the patch site.The patch site was disinfected and cleaned as treatment.The patches were replaced and the procedure was completed with no further adverse consequences to the patient.The reported patches were discarded.It was thought that the amount of adhesive on the patch in combination with the patient's weak skin barrier may have contributed to the reported event.

• Brand Name: ENSITE PRECISION SURF ELECTRODE KIT, JP
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12016527
• MDR Text Key: 256742468
• Report Number: 3008452825-2021-00332
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2021

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: 07/31/2022
• Device Model Number: PRCN-SEK-JP
• Device Lot Number: 7877487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70