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 Extreme Exhaustion (1843); Sleep Dysfunction (2517)

Event Date 11/19/2021

Event Type  Injury  

Event Description

Insomnia was reported to be possibly related to implant procedure and probably related to stimulation/device.The event was noted to be severe.Intervention was taken with the study device as medication change occurred.Lorazepam was increased by 0.25 mg.The insomnia has not resolved.

Event Description

Patient was reported to be experiencing asthenia (50% less energy).Ae was noted to be possibly related to implant procedure and unlikely related to stimulation/device.Event has resolved.No additional relevant information has been received.

Manufacturer Narrative

B5.Describe event or problem - correction - asthenia was inadvertently not reported in initial mdr.F10.Health effect - impact code - code e231201 was not included in initial mdr.

Event Description

Information was received that the asthenia was probably related to stimulation.The information regarding intervention taken was updated to none.No additional relevant information has been received.

• 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: 13205073
• MDR Text Key: 283491001
• Report Number: 1644487-2022-00023
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2022

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: 07/20/2023
• Device Model Number: 8103
• Device Lot Number: 205693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 02/03/2022; 03/21/2022
• Supplement Dates FDA Received: 02/03/2022; 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male