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

Model Number 10-00116102

Device Problems Impedance Problem (2950); Appropriate Term/Code Not Available (3191)

Patient Problem Convulsion/Seizure (4406)

Event Date 07/07/2021

Event Type  Injury  

Event Description

Vegas nerve stimulator implanted 9:20 of 2020 developed high impedance and failed causing increased seizures for patients.Vns was tested five separate times to confirm impedance was greater than 9,000 day of surgery removed old vns and implanted new one (b)(6) 2021 and surgeon and vns representative could not determine what caused the failure.Fda safety report id# (b)(4).

• Brand Name: VEGAS NERVE STIMULATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 12583371
• MDR Text Key: 275220250
• Report Number: MW5104415
• Device Sequence Number: 1
• Product Code: LYJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10-00116102
• Device Catalogue Number: 10-0011-6102
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 88