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 Dysphagia/ Odynophagia (1815); Dyspnea (1816); Convulsion, Clonic (2222)

Event Type  Injury  

Event Description

It was reported that patient is referred for explant due to swallowing and breathing issues.The patient was hospitalized due to these swallowing and breathing issues.No known relevant surgical intervention has occurred to date.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'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 any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that the patient's device was disabled.The patient was noted to have a seizure as a result of the vns.Patient also claims that they had a stroke as a result of vns.Patient has since been removed from the study for being unreasonable and threatening to the study clinicians.No other relevant information has been received to date.

Event Description

It was reported that the patient is referred for explant, the patent was previously requesting explant and it was unclear if this would be granted at the time.Now the patient's wishes have been granted and are referred for explant due to the adverse events the vns is causing.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that the patient has psychological issues unrelated to vns.This will be considered supplemental as the patient has been considered unreasonable and demanding throughout the whole explant process.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15826499
• MDR Text Key: 303932846
• Report Number: 1644487-2022-01460
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2023

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: 09/30/2022
• Device Model Number: 8103
• Device Lot Number: 205433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 01/04/2023; 01/27/2023
• Supplement Dates FDA Received: 12/13/2022; 02/01/2023; 02/21/2023
• Date Device Manufactured: 01/05/2021
• 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): Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male