MAUDE Adverse Event Report: LIVANOVA USA, INC. VAGUS NERVE STIMULATOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED EPILEPSY

Model Number 1000

Device Problems Protective Measures Problem (3015); Unexpected Shutdown (4019)

Patient Problems Pain (1994); Convulsion/Seizure (4406)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Reporter stated that she was implanted with a cyberonics (now livanova) vagus nerve stimulator on (b)(6) 2021.Shortly thereafter around (b)(6) 2022 the stimulator stopped working.She reached out to the manufacturer for help but was given a turnaround with no help at all.She was told to contact her neurologist.Finally she met with her neurologist who tested the device but all they could get was an error message.The neurologist called and spoke to a representative (livanova) and was able to get a technician to her office who tried to repair the device but also got an error message.During this period caller said she started experiencing seizures and pain.

• Brand Name: VAGUS NERVE STIMULATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 14548288
• MDR Text Key: 293148043
• Report Number: MW5109993
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/27/2022

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?: Yes
• Device Model Number: 1000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White