MAUDE Adverse Event Report: LIVANOVA USA, INC. SENTIVA LIVANOVA MODEL 1000; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 1000

Device Problem Protective Measures Problem (3015)

Patient Problem Emotional Changes (1831)

Event Date 09/10/2021

Event Type  Injury  

Event Description

My wife is a brain tumor patient.Vns device - sentiva model 1000, manufactured by livanova was implanted by (b)(6) on (b)(6) 2021, to help "by" wife reduce focal seizures.In (b)(6) of 2021, i can obtain the exact date later, less than 6 months after surgery, my wife was sitting on the couch, and started laughing uncontrollably, as if someone was choking her.I asked if i should call 911, she said, it is ok, it will pass.This was on and off for two days.I wrote to my wife's neurologist - dr (b)(6), and we went to see her on (b)(6) 2021.When dr.(b)(6) connected to this device, it was erroring out.She remotely disconnected the vns device to avoid further damage to my wife/patient - (b)(6).The next day, x-ray showed no micro-fractures, and both doctors and support reps from livanova asked my wife if she fell.She advised she has not.I opened the investigation with livanova - reference# (b)(4).Livanova advised nothing is wrong with the device.I want this investigated, regardless who is at fault - vendor livanova or the medical teams who operated on my wife.Fda safety report id# (b)(4).

• Brand Name: SENTIVA LIVANOVA MODEL 1000
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 13111660
• MDR Text Key: 282989190
• Report Number: MW5106337
• 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
• Type of Report: Initial
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1000
• Device Catalogue Number: 220
• Device Lot Number: 5304293
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ANTI SEIZURE MEDICATIONS; MECHANICAL SHUNT; VNS
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White