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 Dyspnea (1816); Pain (1994); Neck Pain (2433)

Event Date 07/14/2020

Event Type  Injury  

Event Description

It was reported that the patient was experiencing a feeling of strangulation in the lower left neck and shooting pain in the left ear.It was reported that the events occurred with stimulation.The patient's settings were reduced and the events did not resolve.It noted that some local anesthetic was put on the patient's auricular area.It was noted that the patient only felt mild-transient constricting sensations during stimulation, which the patient found tolerable.The pulse width was decreased due to the pain in the face, ear and neck.No additional relevant information has been received to date.

Event Description

It was reported by the physician that local anesthesia was used to see if the pain being experienced was due to the greater auricular nerve being irritated.This was performed in hopes that dividing the nerve through anesthesia would stop the ear pain.It was noted that the local anesthetic did stop the pain inferring that greater auricular irritation is occurring.Per the physician, the throat dyspnea was the main issue for the patient and the anesthesia would not have helped.The patient's output current was adjusted.The patient tolerated the settings better after adjustment.No additional 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
• MDR Report Key: 10379907
• MDR Text Key: 202052669
• Report Number: 1644487-2020-01045
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

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: 11/13/2021
• Device Model Number: 8103
• Device Lot Number: 205157
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR