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); Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/07/2021

Event Type  Injury  

Event Description

A clinical study patient reported numbness and dysphagia that were assessed as definitely related to vns surgery, and not related to device/stimulation.It was also noted that the patient experienced "anesthesia-induced serotonin syndrome" that was "definitely related" to vns surgery, and "possibly related" to other patient condition.It was noted that the patient was hospitalized due to the numbness, dysphagia, and anesthesia-induced serotonin syndrome.No additional relevant information has been received to date.

Manufacturer Narrative

D4 lot # / expiration date / unique identifier (udi) #, corrected data: initial report inadvertently did not include relevant product information.H4 device manufacture date, corrected data: initial report inadvertently did not include relevant mfr 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: 12025708
• MDR Text Key: 257261278
• Report Number: 1644487-2021-00850
• 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
• Report Date: 11/22/2021

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: 03/09/2022
• Device Model Number: 8103
• Device Lot Number: 205379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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): Hospitalization; Other
• Patient Age: 36 YR
• Patient Sex: Male