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 Seizures (2063); Numbness (2415); No Code Available (3191)

Event Date 11/09/2020

Event Type  Injury  

Event Description

It was reported that the patient's magnet was swiped as he had a severe seizure, and he coughed and then noted that he couldn't breathe and his lips turned purple.He fell to the floor and the mother started pumping his chest and blowing air into his face, and then the color came back to his face.It was noted that he was taken to the er but was not admitted to the hospital.It was then reported that the patient's seizures have been increasing and there was concern that this may be due to the vns failing.It was noted that the patient was in the hospital for reports of numbness beginning at the face and radiating down to his toes.It was noted that the vns battery is draining.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was noted in clinic notes that the patient's average seizure remain unchanged with 4-5 brief seizures in the morning now.No other relevant information has been received to date.

Event Description

The patient's generator was replaced.The explanted product has not been received to date.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
• 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: 10960041
• MDR Text Key: 219955854
• Report Number: 1644487-2020-01644
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2019
• Device Model Number: 106
• Device Lot Number: 204215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• 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; Required Intervention; Other
• Patient Age: 26 YR
• Patient Sex: Male