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 Problem Aspiration/Inhalation (1725)

Event Date 04/07/2022

Event Type  Injury  

Event Description

It was reported that a patient is experiencing side effects during magnet mode and some normal stimulation.When he has seizure, swipes with magnet, experiences hiccups and reflux leading to aspiration.They adjusted duty from 10% - 16% and side effects were immediately noticeable, adjusted back down to 10% in same office visit but issues continue w/ magnet swipes, adjusted duty cycle twice and did not tolerated either adjustment.No additional relevant information has been received to date.

Event Description

It was later reported that the physician is to disable therapy for the patient.When asked why it was noted that the disablement was due to the same stimulation related events previously reported.No other relevant information has been received to date.

Manufacturer Narrative

Supplemental #1 inadvertently omitted f7 type of report data - 'follow up' version '01'.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14269431
• MDR Text Key: 290690098
• Report Number: 1644487-2022-00505
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/24/2023
• Device Model Number: 1000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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: 7 YR
• Patient Sex: Male