MAUDE Adverse Event Report: LIVANOVA USA, INC. SYMMETRY; GENERATOR

Model Number 8103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Code Available (3191)

Event Date 05/17/2020

Event Type  Injury  

Event Description

It was reported that a clinical study patient experienced transient aphasia that was classified as a "transient ischemic attack," as well as orthostatic hypotension.It was assessed that the hypotension is possibly related to the vns stimulation, the vns device, and/or the implant procedure.The transient ischemic attack is assessed as possibly related to vns stimulation and/or the vns device.The patient was hospitalized for both events.The transient ischemic attacks have resolved.No additional relevant information has been received to date.

Event Description

Additional information was received indicating that the aphasia (previously reported as transient ischemic attack) and postural hypotension have been attributed to guillain-barre syndrome and will be considered the same event.No additional relevant information has been received to date.

Event Description

Additional information was received from the physician indicating that the patient's guillain-barre/hypotension and dizziness issues were unrelated to the vns device and/or study procedure.No additional relevant information has been received to date.

• Brand Name: SYMMETRY
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10159759
• MDR Text Key: 195309664
• Report Number: 1644487-2020-00814
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2021

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: 08/12/2021
• Device Model Number: 8103
• Device Lot Number: 205038
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 10/02/2020; 03/01/2021
• Supplement Dates FDA Received: 10/27/2020; 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other