MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 304-20

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

Patient Problems Dyspnea (1816); Undesired Nerve Stimulation (1980); Neck Pain (2433); No Code Available (3191)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

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.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8127177
• MDR Text Key: 129146547
• Report Number: 1644487-2018-02197
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• 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 Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2017
• Device Model Number: 304-20
• Device Lot Number: 202731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2013
• 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): Required Intervention
• Patient Age: 51 YR