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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. LIVEWIRE? ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL; CATHETER, ELECTRODE RECORDING Back to Search Results
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.
 
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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 Key4523674
MDR Text Key19088629
Report Number3005188751-2015-00013
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K022380
Number of Events Reported1
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 Date12/31/2016
Device Model Number401908
Device Lot Number4423274
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2015
Initial Date FDA Received02/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BARD DIAGNOSTIC CATHETERS X 2; TACTICATH QUARTZ ABLATION CATHETER
Patient Outcome(s) Required Intervention;
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