MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Nerve Damage (1979); Paralysis (1997); Depression (2361); Syncope/Fainting (4411)

Event Date 05/15/2014

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported by the patient the she had been implanted with vns for approximately 8 years.About 2.5 years ago, it was noted there was an issue with her lead and it needed to be replaced.She noted immediately after surgery she had vocal cord paralysis and she has to have a second surgery by an ent to make the vocal cord mobile.After that, she has problems swallowing.The patient's psychiatrist noted the patient was programmed off prior to (b)(6) 2016 due to an mri and it was decided to leave the patient programmed off.The psychiatrist stated that the patient noted only slight improvement since that time.She noted the patient had seen an ent (ear, nose, and throat) who showed the patient had little to no peristalsis.The patient called again and noted she had a history of chest pain which got worse.She noted the vns was programmed off and there was only slight improvement.The psychiatrist was called and it was noted that since programming the device off, the patient did not notice much difference; however, she was more depresses.The psychiatrist decided to leave the device programmed off due to the low peristalsis.The patient called again and stated she had permanent damage to her esophagus and her vocal cords due to vns.The issue with the patient's lead about 2.5 years ago has previously been captured in mfr.Report 1644487-2014-01151.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The psychiatrist reported about patient's continuing difficulty swallowing which has been a recurring event since the device disablement.The psychiatrist does not know the cause of the swallowing issues and doesn¿t know if it is related to the vns.

Event Description

The reported that the vagus nerve was also damaged during their replacement and that ever since then, whenever they eat their vision will go dark and she¿ll pass out.The patient reported that their generator was still off and that the symptoms had been worse prior to being disabled but that she has still be experiencing the dysphagia, and syncope which she believes is due to her vocal cords and vagus nerve being damaged.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 5804912
• MDR Text Key: 49944117
• Report Number: 1644487-2016-01626
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2021

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: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 103
• Device Lot Number: 3781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided; 04/16/2021
• Supplement Dates FDA Received: 04/23/2017; 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2013
• 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: 53 YR