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 Convulsion, Clonic (2222); Weight Changes (2607)

Event Date 11/08/2021

Event Type  Injury  

Event Description

It was reported by the surgeon that the patient's family was insistent on having the patient's vns removed because of weight loss and change in seizure type.While the family attributed the events to the metal in his body, the surgeon was uncertain as to whether the vns had contributed to the weight loss or change in seizures.The surgeon didn't believe it was related to the metal.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

The doctor reported there was no change in seizure type or worsening in seizures and that the weight change was 5 lbs weight loss.No further relevant information has been received to date.

Manufacturer Narrative

H3.Device evaluated by mfr? code 81, return and evaluation of device is not needed as the cause of the reportable event was determined to have been confirmed invalid.

Event Description

Information received that he patient is part of a study and the device was explanted due to lack of efficacy.No additional relevant information has been received to date.

• 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: 13078103
• MDR Text Key: 282716677
• Report Number: 1644487-2021-01820
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2022

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: 05/20/2021
• Device Model Number: 1000
• Device Lot Number: 6337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 12/30/2021; 03/16/2022
• Supplement Dates FDA Received: 01/18/2022; 04/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2019
• 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: 29 YR
• Patient Sex: Female