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

Model Number 304-20

Device Problem Positioning Problem (3009)

Patient Problems Dyspnea (1816); Inflammation (1932); Muscle Spasm(s) (1966); Paralysis (1997); Dysphasia (2195); Complaint, Ill-Defined (2331); Choking (2464); Sleep Dysfunction (2517); Weight Changes (2607); Patient Problem/Medical Problem (2688)

Event Date 07/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient was having dyspnea and voice alteration.The symptoms occurred even between stimulations.Diagnostics were within normal limits.The physician decided to disable the device to see if the symptoms get better.The patient was still experiencing vocal cord problems even with the generator programmed off.The vocal cord issue did not start until later into the titration phase and did not resolve with the disablement, so the physician believed that the nerve was inflamed and wanted to wait and titrate the device up again.The patient later reported that her implant surgery took two times as long as it should have because the surgeon had difficulty implanting the lead.While in recovery, she choked on water and could not swallow.The patient lost a large amount of weight because she could not swallow food.She also reported that she was diagnosed by an ent with left vocal cord paralysis, spasms in the trachea and esophagus, and damage to the swallow and sensory nerves.Due to these issues, she could not talk, breathe, or sleep.The left side of her face was also reportedly paralyzed.The patient was having speech and swallow therapy, but she was told that this would not help.The physician considered disabling the patient's device to allow inflammation at the nerve to go down, but the patient was receiving efficacy from vns therapy.The physician decided program the patient's device to low settings for all modes of stimulation.No further intervention was taken.No additional information has been received to date.

Event Description

The patient's device was programmed off, and the patient reportedly had unspecified issues caused by her battery.No further relevant information has been received to date.

Event Description

The patient was referred for explant due to voice hoarseness and generator migration.The migration of the generator is housed in mfr report # 1644487-2019-00818.No additional relevant information has been received to date.Surgery is likely but has not occurred to date.

Event Description

Patient's generator was explanted.The migration of the generator is housed in mfr report # 1644487-2019-00818.No additional 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: 6150194
• MDR Text Key: 61595767
• Report Number: 1644487-2016-02809
• 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: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2019
• Device Model Number: 304-20
• Device Lot Number: 4227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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: 44 YR