MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 08/01/2016

Event Type  Injury  

Event Description

It was initially reported the patient had vns generator replacement.When following up with the physician's office for the reason for the replacement, it was noted the patient's device was last replaced several years ago and the patient had experienced an increase in seizures.It is unknown if the increase in seizures was below, at, or above the patient's pre-vns baseline levels.Prior to the physician's response as to the reason for the replacement, the generator had been received by the manufacturer for product analysis (pa).Pa had found there was no indication from the device that an end of service condition had existed.The device performed according to functional specifications and pa concluded that no abnormal performance or any other type of adverse conditions were found.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Clinic notes were later received reporting that the patient had bad seizures back in 2016 due to the generator's depleted battery.Moving forward, the physician's plans were to always refer the patient for a replacement if the battery was ever observed less that twenty five percent.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 6183164
• MDR Text Key: 62680011
• Report Number: 1644487-2016-02905
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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: 06/27/2013
• Device Model Number: 102
• Device Lot Number: 3077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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
• Patient Age: 37 YR
• Patient Sex: Female