MAUDE Adverse Event Report: LIVANOVA USA, INC. SYMMETRY GEN MODEL 8103; GENERATOR

Model Number 8103

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

Patient Problem Suicidal Ideation (4429)

Event Date 06/08/2023

Event Type  Injury  

Event Description

It was reported that the patient started having increased suicidal ideations possibly related to vns stimulation.Additionally, it was noted that when the patient was seen for a follow up after activation for further programming she noted increased irritability and desire to shop, which she indicated she is concerned may be signs of mania.However, per the physician, the increased irritability and desire to shop are new and do not meet criteria for hypomania or mania.The cause is probably natural fluctuation in illness, but it is possible that symptoms are related to vns stimulation.The suicidal ideation is more frequent than pre-vns, but still passive and not requiring specific intervention.Additionally the patient, is scheduled to see her primary psychiatrist and a change in medication may be indicated which was confirmed to be for patient comfort, not to preclude serious injury.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova 39;s employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any4;defects¿ or 4;malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

New information was received reporting that the outcome was updated to recovered/ resolved with sequelae.No other relevant information has been received to date.

• Brand Name: SYMMETRY GEN MODEL 8103
• 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: 17231108
• MDR Text Key: 318142974
• Report Number: 1644487-2023-00836
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• 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
• Report Date: 04/22/2024

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 Model Number: 8103
• Device Lot Number: 7457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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: 69 YR
• Patient Sex: Female