MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE? ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL; CATHETER, ELECTRODE RECORDING

Model Number 401908

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

Patient Problems Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109)

Event Date 02/02/2015

Event Type  Injury  

Event Description

During a ventricular tachycardia ablation procedure using a livewire ep catheter, a neurologic event occurred.Geometry was being created in the left ventricle with a livewire ep catheter when the patient complained of feeling sick and having vision problems.The procedure was stopped to evaluate the patient.The patient then stated feeling better.A ct scan was performed with no results available.There were no performance issues noted with any sjm device used.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and completed in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported neurologic event could not be conclusively determined.Per the ifu, thromboembolism is a known risk with the use of this device.

• Brand Name: LIVEWIRE? ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4523674
• MDR Text Key: 19088629
• Report Number: 3005188751-2015-00013
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K022380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2015

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: 12/31/2016
• Device Model Number: 401908
• Device Lot Number: 4423274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2014
• 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
• Treatment: BARD DIAGNOSTIC CATHETERS X 2; TACTICATH QUARTZ ABLATION CATHETER
• Patient Outcome(s): Required Intervention