MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number EN0020-P

Device Problem Difficult to Remove (1528)

Patient Problem Skin Tears (2516)

Event Date 02/13/2018

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 skin tear could not be conclusively determined.

Event Description

Following a pulmonary vein isolation procedure, a skin tear was noted.After the procedure, difficulty was noted while removing the patch near the mid axilla of the patient and a skin tear and bruising were noted.The tissue was washed with saline and treated in mepilex dressing.The patient was known to bleed and bruise easily since the patient was obese and on blood thinners.The patient was discharged from the hospital.

• Brand Name: ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7310827
• MDR Text Key: 101436129
• Report Number: 3008452825-2018-00067
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160186
• 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: 03/02/2018

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: 05/31/2018
• Device Model Number: EN0020-P
• Device Lot Number: 6233002
• Other Device ID Number: 05415067025937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2017
• 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 Age: 74 YR
• Patient Weight: 85