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

Model Number 1000

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 01/18/2024

Event Type  Injury  

Event Description

My son had his vagus nerve stimulator replaced on (b)(6) 2023.In pre-op the vns was queried and was working (low battery).During surgery the vns was replaced with a new unit, different from prior models.The surgeon states a lead was found to be broken when she began the surgery.That does not explain why it was operating an hour prior to him entering the or (operating room).He would need/require the leads replaced in a future surgery.Last lead replacement was (b)(6) 2018.(b)(6) 2023 swelling and pain were noted over implant site.Ultrasound noted a pocket of fluid over the device.Surgery to replace the leads was (b)(6) 2024.Surgeon reports during the surgery a small crew from the vns was found loose in the patient.In addition to the new leads the vns device from the surgery (b)(6) 2023 had to be replaced.The device was returned to the manufacturer to inspect.It should be under warranty.The rep from the manufacturer failed to provide me with the paperwork (warranty, registration, device serial number) from the surgery on (b)(6) 2024.My son's neurologist contacted him and i was mailed the paperwork.The surgeon told me the company will decide if the vns device implanted on (b)(6) 2023 was defective.My son does not have a screwdriver inside of his chest which could have caused this, so i am certain it is defective and should be looked into by the fda.His original vns was implanted in 2000 and he has had numerous replacements in his life.His leads from the original surgery in (b)(6) 2000 corroded and were replaced (b)(6) 2018 (that was reported to you at the time).The ultrasound of his chest in (b)(6) 2023 was done at (b)(6) medical center in (b)(6).Livanova sentiva #1000 sn (b)(6).Surgeries on (b)(6) 2023 and (b)(6) 2024 were at (b)(6) medical center, (b)(6).Reference report: mw5152581.

• Brand Name: SENTIVA VAGUS NERVE STIMULATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 18876853
• MDR Text Key: 337588239
• Report Number: MW5152580
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/06/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2024
• Patient Sequence Number: 1
• Treatment: BANZEL.; DEPAKOTE SPRINKLES.; ONFI.; RISPERDAL.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White