MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Detachment Of Device Component (1104); High impedance (1291)

Patient Problems Headache (1880); Pain (1994); Neck Pain (2433); No Code Available (3191)

Event Date 10/21/2015

Event Type  malfunction  

Event Description

It was reported in october 2015 that the patient had been experiencing a sore throat, earaches and headaches since the suspect device was implanted 5 months prior.The issues had began when her physician had began to titrate her device settings.Due to the symptoms, then turned back on to lower settings in (b)(6) 2015.Device diagnostics were within normal limits at this time.In (b)(6) 2016, the patient again began to experience jaw pain, ear aches and headaches after her physician increased her settings.Device diagnostics were within normal limits, per the physician.Her output current was reduced.In (b)(6) 2017 the patient reported that she was still unable to increase vns settings due to tolerability issues.The physician indicated that the patient had had x-rays and the radiologist indicated that the patient's electrodes had moved in comparison to x-rays from (b)(6) 2015.The manufacturer reviewed the x--rays from (b)(6) 2017 and no obvious anomalies or lead discontinuities were found.The lead's strain relief was not per labeling.The physician's office indicated that the patient had high impedance in (b)(6) 2015.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

X-rays from (b)(6) 2015 were reviewed by company representatives.No difference was noted in lead placement between these and the x-rays from (b)(6) 2017.The patient indicated that she was concerned about how much higher the electrodes were on her current lead in comparison to her previous lead.She wondered if it was "too high" and believed that could be causing her to be more sensitive to stimulation.Programming history showed that the patient did not have high impedance on (b)(6) 2015 as reported by the physician's office.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

It was reported that the patient's device had been disabled for some time due to adverse events with stimulation including throat pain which radiated to the ear and stimulation related hoarseness.Diagnostics were ok no further relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• 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: 6822969
• MDR Text Key: 83732919
• Report Number: 1644487-2017-04385
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Report Date: 02/04/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/23/2018
• Device Model Number: 304-20
• Device Lot Number: 4045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 09/05/2017; 01/10/2019
• Supplement Dates FDA Received: 09/29/2017; 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR