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 Problems Anxiety (2328); Depression (2361); No Code Available (3191)

Event Date 11/22/2020

Event Type  malfunction  

Event Description

The patient reported an increased frequency of suicidal ideations.No other relevant information has been received to date.

Event Description

The patient is also experiencing worsening depression.

Manufacturer Narrative

Section b2.Outcomes attributed to adverse event: corrected data; initial mdr inadvertently did not check 'other serious'.

Event Description

The patient experienced anxiety.

Manufacturer Narrative

Section b5.Describe event or problem: corrected data; supplemental mdr 3 did not include that the event is resolving.Section f10.Adverse event problem| health effect - clinical code: corrected data; supplemental mdr 3 inadvertently did not code anxiety.Section f7.Type of report | follow-up #: corrected data; supplemental mdr 3 inadvertently listed follow-up # 1 instead of 3.

Event Description

The event is resolving.

Event Description

Additional information received noting the outcome for the worsening depression and suicidal ideations is now 'recovered/resolved'.

Event Description

Additional information received noting that worsening depression is possibly related to the implant procedure.It was also reported that the anxiety and suicidal ideations were both found to not be related to the vns.

• Brand Name: SYMMETRY GEN MODEL 8103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; cyberonics - houston; 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: 11065825
• MDR Text Key: 223414077
• Report Number: 1644487-2020-01741
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/09/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2022
• Device Model Number: 8103
• Device Lot Number: 205219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 12/23/2020; 02/26/2021; 04/27/2021; 06/18/2021; 12/02/2021; 09/14/2023
• Supplement Dates FDA Received: 01/15/2021; 03/23/2021; 05/21/2021; 06/18/2021; 12/22/2021; 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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: 66 YR
• Patient Sex: Female