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 Headache (1880); Nausea (1970); Neck Pain (2433)

Event Date 09/23/2021

Event Type  Injury  

Event Description

Patient reported experiencing severe neck pain, headaches, throat hoarseness and continued nausea and vomiting.The patient's settings were lowered and they were referred for a consult with neurosurgery.The surgeon assessed that there were no issues with the placement of the vns but that the patient did have a small vagus nerve so he suggested that the patient have the device turned off and explanted.The patient felt no relief from having their settings lowered so they had their device completely turned off.Additional information obtained indicating that the patient had nausea, vomiting, headaches and neck pain all prior to having the vns implanted.But it was assessed that the vns has exacerbated these issues for the patient.The patient has been able to treat the nausea and vomiting but the neck pain hasn't gotten any better and the patient wants to move forward with getting the device removed.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The throat hoarseness, neck pain and headaches were all noted to still be ongoing and the neck pain was noted to cause the patient to discontinue from the study.

Event Description

Additional information received noting that the outcome for the reported throat hoarseness, headaches and neck pain is now recovered/resolved.

Event Description

Additional information received noting that the outcome for the reported throat hoarseness, headaches and neck pain is now not recovered/ not resolved.

Event Description

Additional information received noting that neck pain, headaches and throat hoarseness all now have an outcome of recovered/ resolved.

Event Description

Additional information received noting that neck pain, headaches and throat hoarseness all now have an outcome of not recovered/ not resolved.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 13732777
• MDR Text Key: 287013431
• Report Number: 1644487-2022-00242
• 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,Followup,Followup,Followup
• Report Date: 07/25/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/12/2021
• Device Model Number: 8103
• Device Lot Number: 205038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 03/29/2022; 06/23/2022; 02/24/2023; 04/05/2023; 06/30/2023
• Supplement Dates FDA Received: 04/22/2022; 07/18/2022; 03/20/2023; 04/28/2023; 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2019
• 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 Age: 36 YR
• Patient Sex: Female