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 Muscle Weakness (1967); Paresis (1998)

Event Date 03/24/2021

Event Type  Injury  

Event Description

The nurse reported that the patient was diagnosed with myasthenia gravis secondary to covid-19, and the family questions whether the vns may be complicating the case.It was noted that the patient was experiencing right sided ptosis, excess salivation, and facial droop that has been worsening.He was evaluated by neuro ophthalmology and diagnosed with myasthenia gravis secondary to covid-19.He also has right lower motor neuron facial palsy and they are unsure of left side involvement.The nurse asked if the vns can contribute to this issue.The patient's mother would like the vns turned off.It was noted that the patient has also undergone right hemispherectomy due to hemimegalencephaly with intractable epilepsy.A detailed assessment from the ophthalmologist was also provided.It states "new onset weakness of abduction and depression of right eye associated with fluctuating ptosis and nonconcomitant exotropia consistent with partial right 3rd cranial nerve palsy.This is involving incompletely the superior segment of the 3rd cranial nerve.It is also associated with a right lower motor neuron facial palsy manifested by orbicularis weakness, right lip droop, drooling from the right side of his mouth, and frontalis weakness.Finally he also has tongue deviation to the right indicating impact on the right 12th cranial nerve.The fluctuating nature of this associated with fatigue is most consistent with neuromotor process such as myasthenia." other possible diagnoses were noted to be miller fisher syndrome or multiple cranial nerve problems secondary to covid.No other relevant information has been received to date.

Event Description

Information was received from the nurse that the symptoms not believed to be related in any way.It was noted that the vns was turned off per the patient's mother's request for patient comfort.No further 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
• MDR Report Key: 11678890
• MDR Text Key: 245808584
• Report Number: 1644487-2021-00521
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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: 01/12/2019
• Device Model Number: 106
• Device Lot Number: 5168
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 17 YR