MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Seizures (2063); Sleep Dysfunction (2517); No Code Available (3191)

Event Date 06/03/2019

Event Type  malfunction  

Event Description

Information was received from the nurse of the patient that the mother has reported the patient suffers from insomnia, coughing and held chest when vns was turned off, incision in neck has been quite red and patient has been rubbing on it, pain, and when vns was turned off using magnet by keeping it in place the patient had 8 seizures.The seizures seemed to be post ictal and have been getting worse with the patient waking up tonic/clonic which is unusual.The patient woke up not being able to walk.Weird auras have been returning and the patient is not eating much, spending a lot of time chewing and not swallowing.There is also pain at the scar in the neck.The patient has had some cognitive changes appearing zombified and not talking.The device appears to not be off at this time as it was indicated that if vns is causing these events, the device needs to be turned off.Information was later received from the nurse that with this device the patient has complained of throat hurting.Patient was scheduled for antibiotics for two weeks however it was not indicated what the antibiotics were for.The patient turned off their vns using the magnet one night and only had one seizure as opposed to the 12 seizures in 12 hrs the patient had the previous day.The physician asked for the device to be turned off for a month in order to determine the patient's pre-vns baseline which would also give time for the antibiotics to finish up for the chest infection to clear up.The infection was reported in manufacturing report #1644487-2019-01954.The patient has also had some twitching.At this time, additional relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the nurse that the patient was seen since the trial of having vns turned off.The parents of the patient indicated that after having the device turned off for a few days, the symptoms such as exacerbation, increase in seizures, difficulty eating particularly swallowing and reduction is communication have all improved.The device was turned off for a month and when they came in clinic, they were doing well.It was indicated that the nurse's clinical judgment is that the stimulation of vns was causing all of these symptoms.Two trials were performed, with vns on and off.It was also indicated that prior to the patient coming in to have the device turned off, they were advised that they try taping the magnet over the device to switch it off but when the patient came in, it could be seen that the patient received extra stimulation.The system diagnostics performed indicated there were no problems with the device at all.The nurse stated that it was strange previous models the patient had tolerated much higher settings.The patient's parents are keen to continue and explore different settings to determine what will work for the patient, however at this time the device has been turned on to low output current of 0.25ma and duty cycle of 10%.Autostim has been left off due to concern it may be contributing the side effects of the patient.They will be returning in a month.Information was received from the nurse that there was no infection at the generator site and no allergic reaction at the electrode site.The infection was initially reported in manufacturing report #1644487-2019-01954, therefore a supplemental report was submitted.It was indicated that the following adverse events were found to be related to vns stimulation: sleep disturbance ¿ causing an increase in seizures, painful stimulation, dysphagia, coughing, muscle spasms, decrease in appetite, ambulation difficulties, altered cognition.At this time, since all the listed adverse events were found to be associated to vns and linked to one another leading to the increase in seizures, they will also be reported.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9167340
• MDR Text Key: 161714016
• Report Number: 1644487-2019-01955
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2021
• Device Model Number: 1000
• Device Lot Number: 204795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR