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

Model Number STILL INSIDE HER BODY

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Rupture (2208)

Event Date 07/10/2012

Event Type  Injury  

Event Description

Surgery to replace battery of vagal nerve stimulator (vns).Came home after surgery and then 30 days later there was a hole in her skin where the device had worn through from the inside out.Very painful and had to have a second surgery to fix it.Went on strong antibiotics to prevent infection.Fda safety report id # (b)(4).

• Brand Name: VAGUS NERVE STIMULATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 8912261
• MDR Text Key: 155114226
• Report Number: MW5089180
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STILL INSIDE HER BODY
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 19 YR
• Patient Weight: 50