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 Problem Depression (2361)

Event Date 06/13/2022

Event Type  Injury  

Event Description

It was reported that patient's vns has worked for both epilepsy and depression but has noticed a little increase in depressive symptoms but nothing severe or awful.Physician reported it may be related to the vns or it could be altogether separate.They will see after her generator is replaced.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Provider later reported that the cause of increase in seizures is external factors, not vns.The increased depression is also above pre-vns baseline levels.

Event Description

It was later reported that patient had a prophylactic generator replacement.Product return is not necessary as it is already known the increased depression is not related to vns therapy, therefore analysis will not add any value to the investigation.

Manufacturer Narrative

H3.Code 81 - device evaluation is not necessary because the reported event has been determined as not related to vns therapy.H3 other text: 81.

• 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: 14959504
• MDR Text Key: 295598976
• Report Number: 1644487-2022-00820
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/17/2019
• Device Model Number: 106
• Device Lot Number: 204205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2017
• 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): Other
• Patient Age: 53 YR
• Patient Sex: Female