MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems High impedance (1291); Device Inoperable (1663)

Patient Problem Fibrosis (3167)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that vns patient feels that the generator is no longer working.Patient does not feel the auto stimulation anymore.Information received from patient neurologist visiting the patient that the battery seemed to be ok, and it looked like fibrosis.Additional information was received that vns system was interrogated on (b)(6) 2016 and high lead impedance found.Physician suspects' fibrosis.Further clarification was received from patient that they cannot feel the auto simulation which was every 5 minutes anymore but that could have been also because of body getting used to it.It was reported that patient got worried when they needed to use the magnet and haven't sensed anything after using it.Patient does not have increase in seizures.Additional information was received that when patient used the magnet during the aura they didn't need that longer period to recover and did not need to lie down to stop the seizure.During the last visit when high impedance found, device settings were change to see if patient could feel stimulation which was not the case and patient saw then programmed back to the previous settings.Patient trauma is not believed to have caused or contributed to the high impedance.No known surgical interventions have occurred to date.

Event Description

Additional information was received from patient that on (b)(6) 2016 patient had quite a complex seizure in sleep.Type of seizure that patient didn't had for some period in which patient woke up from the bed, pushed himself back in bed with the hands and then started trembling (a normal part of the seizure).Patient reported they don't guarantee that the vns would have stopped the seizure if it would have worked but the chances would have been to be lighter.Patient reported that during the week before had almost daily problems which seems more like vertigos not epileptic seizures in which he doesn't loose conscience or tremble but needs to close the eyes because everything moves and also needs to lay down because of the feeling of loosing all the strength in the muscles.Patient had to call the ambulance and had blood test in the hospital but the vns system wasn't checked.

Manufacturer Narrative

The previously submitted mdr inadvertently provided the wrong suspect device for the event.Device manufacture date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device manufacture date for the event.

Event Description

Additional information was received that patient had a follow up visit with their neurologist who found out that the connection between the vagus nerve and the vns isn't working.Patient was referred for surgery as it was concluded that there is no power in the battery.Patient underwent surgery on (b)(6) 2016.It was reported that during the surgery a lead break was observed and full vns system replaced.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5519604
• MDR Text Key: 41307102
• Report Number: 1644487-2016-00625
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 304-20
• Device Lot Number: 202577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2013
• 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 Age: 35 YR