MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Cyanosis (1798); Paralysis (1997); Paresis (1998)

Event Date 08/02/2023

Event Type  Injury  

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿rhinitis¿ is not available.Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.Health effect - clinical code :e2115, health effect - clinical code :e0717, health effect - clinical code :e2402, health effect - clinical code :e1623.

Event Description

It was reported that the patient is experiencing vocal cord paralysis.It was noted that the patient needed a tracheotomy due to cyanosis in which the relation to vns is currently unknown at the time of reporting.Additional information from physician noted that in the past three months, the patient suffered from dyspnea when performing physical exercises.When patient was on holiday, they developed rhinitis, throat pain, then laborious and noisy respiration and palor.Due to this, patient went to the emergency department where cortisone and oxygen was prescribed.Fibroscopy was performed and complete paralysis of left vocal cord and paresia on the right was observed.Tracheotomy was performed the next day due to worsening of right paresia.Tracheostomy was now noted to be closed, right vocal cord is still in paresis but strong reactivity when stimulated, left vocal cord notes to still be in paralysis with weak reaction to stimulation.A historical data analysis review was completed and the event of vocal cord paralysis and paresis is consistent with the findings of the investigation.The cause of these events is therefore concluded to be due to vns surgery.The cause of the cyanosis as well as the newly reported events of infection, rhinitis, throat pain, dyspnea, and neck pain are unknown at this time.Physician noted their hypothesis is a viral infection on the vocal cords, the left one being previously partially damaged.Cause of this infection is still unknown at this time.At this time there is no reason to believe the infection of the vocal cords is alleged against the leads and likely attributed to surgery and/or stimulation as the physician indicated regarding the other events.Device history records were reviewed for the device, the device passed all functional and quality testing prior to distribution.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 17627073
• MDR Text Key: 322021317
• Report Number: 1644487-2023-01174
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2023

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: 04/13/2018
• Device Model Number: 106
• Device Lot Number: 4872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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; Disability; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Male