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LIVANOVA USA, INC. LEAD MODEL 302 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury  
Manufacturer Narrative


Event Description

It was reported that the patient experienced painful stimulation at the electrode site in the neck in the middle of the night for 10-15 minutes. Additionally, clinic notes from the next day indicated that the patient had experienced a very severe cough, voice alteration, sharp pain sensations in left arm/shoulder and chest, as well as shortness of breath. The patient's device was disabled due to these adverse events. The patient reported that the device stimulated despite the disablement and that the voice alteration and pain persisted with the device being programmed off. The patient had not experienced any known trauma. The physician reported that the patient's adverse events were likely due to a lead malfunction, however, device diagnostics for the patient were within normal limits. The physician indicated the patient would be referred for a generator and lead replacement for patient comfort and to preclude a serious injury, and that the patient's battery was low. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

Event Description

The explanted generator was received for product analysis. The generator underwent product analysis and proper functionality of the generator in its ability to provide appropriate programmed output currents was successfully verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids to unintended sites. The device output signal was monitored and results should no signs of variation in the pulse generator's output signal. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator. No further relevant information has been received to date.

Event Description

The physician indicated that the patient's lead could be seen under the skin, and that the reported adverse events were likely related to lead malfunction. No further relevant information has been received to date.

Event Description

It was reported that the patient's vns generator was explanted. It was also reported that the lead was not explanted during the surgery. No further relevant information has been received to date.

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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key8127177
Report Number1644487-2018-02197
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/19/2017
Device MODEL Number304-20
Device LOT Number202731
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/28/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/28/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/24/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 12/03/2018 Patient Sequence Number: 1