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

Model Number M 1000

Device Problem Defective Device (2588)

Patient Problems Dysphagia/ Odynophagia (1815); Burning Sensation (2146); Sore Throat (2396)

Event Date 01/14/2021

Event Type  Injury  

Event Description

My son has the livanova sentiva m1000 serial number (b)(4).It has been going off for different amounts of time no matter how the setting is if has magnet swipes recorded that never happened.Even while being hospitalized and the doctors seeing this happen, we are just troubleshooting meantime, my son is getting burning pains when it goes off and those are rare.However, the inconsistency of this device is apparently very consistent.The on call dr did a complete shut down and restart of the device (which is only supposed to be done in an operating room).In our room.When this was done everything was erased from the device.But, the errors are still coming.They have reached out to livanova tech support, as well as the rep.But, have done nothing to help my son ((b)(6)) until livanova gets here.I have pictures and doctors notes.I asked yesterday if this had been reported yet and was told it hasn't been, but it will be.After all of the troubleshooting that they had to do, they became worried about laryngospasms i had to hold down my son, while they stuck a scope down his nose thankfully, it was not "laryngospasms" but, the issues are so intermittent, and they refuse to replace the device, repeatedly saying my son is "sensitive".They have decided that it is not causing laryngospasms, per the ent that performed this test.We are home now and (b)(6) is still unable to eat as his throat is so sore.He is only drinking shakes.Fda safety report id # (b)(4).

• Brand Name: VNS
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 11229124
• MDR Text Key: 228954381
• Report Number: MW5098996
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M 1000
• 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; Required Intervention
• Patient Age: 54 YR