MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Cardiac Arrest (1762); Status Epilepticus (4408)

Event Date 04/26/2022

Event Type  Injury  

Event Description

It was reported that a patient was transported to the hospital due to status epileptics and was given nasal drop of midazolam 3 mg, she fell into cardiopulmonary arrest due to respiratory depression and was resuscitated by cpr.After that, she was transferred to a different hospital with tracheal intubation and mechanical ventilation.The patient¿s primary disease is intractable epilepsy associated with scn8a gene abnormality (eiee13).The patient had a covid19 test that was positive.No additional relevant information has been received to date.

Manufacturer Narrative

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.

Event Description

Information was received that the patient was later transferred from the children's hospital to another hospital.No additional relevant information has been received to date.

Event Description

Patient had tracheal intubation and respirator still attached when transfer to hospital.No treatment was provided.Outcome of the patient was continued hospitalization with tracheal intubation and ventilator attached.Continued to use with the vns device implanted on the right side as it was.There are currently no indications of device malfunction.The doctor says the possibility cannot be denied that there was any problem with the output state of the device when status epilepticus occurred.However, no indication of any device malfunction is currently observed, and the current condition (continued hospitalization with tracheal intubation and ventilator attached) is due to covid-19 infection.The infection positive (covid) was found at checking when the patient was brought to the hospital due to the status epilepticus.

• Brand Name: PULSE GEN MODEL 1000
• 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: 14492650
• MDR Text Key: 292586940
• Report Number: 1644487-2022-00600
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2022

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: 04/07/2022
• Device Model Number: 1000
• Device Lot Number: 205309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 09/25/2022; 10/27/2022
• Supplement Dates FDA Received: 10/20/2022; 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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): Life Threatening; Hospitalization
• Patient Age: 4 YR
• Patient Sex: Female