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

Model Number 103

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

Patient Problems Chest Pain (1776); Twitching (2172); Convulsion, Clonic (2222); Neck Pain (2433); Status Epilepticus (4408)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported that their vns stimulation felt stronger and had become painful for them so the patient went to the er.The er physician noted that the patient's heart rate would increase with stimulation and they would also clench their upper extremities each time.It was then noted that the patient was admitted into the hospital.No other relevant information has been received to date.

Event Description

Additional information received indicating that this patient is currently on a ventilator and their device has been going off often and the magnet did not stop stimulation.It was also noted that patient had not been compliant with their medication.The patient was then seen again in the er reporting constant stimulation as well as breakthrough seizures.

Event Description

Additional information received noting that the patient reported no longer being able to feel magnet stimulation and was seen in the emergency room.The patient then went into status and was intubated for airway protection.

• 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: 11680498
• MDR Text Key: 245848875
• Report Number: 1644487-2021-00529
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2022

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: 07/11/2016
• Device Model Number: 103
• Device Lot Number: 203094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 04/01/2022; 10/23/2022
• Supplement Dates FDA Received: 04/26/2022; 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2014
• 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): Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female