MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Leak/Splash (1354); Material Protrusion/Extrusion (2979)

Patient Problems Purulent Discharge (1812); Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

Suspect udi: (b)(4).

Event Description

Information was received indicating that the patient had voice alteration independent of stimulation.The surgeon indicated that the patient's nerve might have been cut during surgery on (b)(6) 2016.Stimulation was turned on (b)(6) 2016.Since then the patient's settings have been reduced to lower settings and autostim has been turned off for patient comfort.Diagnostics from (b)(6) 2016 were within normal limits.There was also report of drainage of pus at the neck incision site as well as pain.Blood tests were run and there was no sign of infection, but antibiotics were prescribed.The leakage increased when the patient laid down.In addition to the drainage at the neck site the generator was found to be protruding.There was also flushing and pain present around the generator site.No other relevant information has been received to date.

Event Description

X-rays were received to review if the patient had a lead fracture that might have been contributing to the reported events.The review found that the lead pin was properly inserted, adequate strain relief was present, and no gross fractures could be visualized.However the possibility of micro fractures that could not be visualized with naked eye were not ruled out.The patient's lead and generator were then explanted on (b)(6) 2016 and during the explant surgery it was discovered the patient had an infection despite having a negative cbc count.The infection appeared to be wide spread extending from the generator site to the lead site and causing the drainage at the electrode site.During surgery there was no nerve damage noted which the surgeon had mentioned as a possibility prior.The patient had antibiotics prescribed to treat the infection and had the entire vns system removed.The vns system was then discarded by the explanting facility.The surgeon and physician did not know what caused the infection.Patient behavior was discussed as a possibility but no conclusive decision was found.The device history record for the generator and lead were reviewed and both devices were found to be sterilized prior to shipment.The expiration dates were 01/18/2019 and 01/22/2017 for the lead and generator, respectively.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 6031171
• MDR Text Key: 57498902
• Report Number: 1644487-2016-02355
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2019
• Device Model Number: 302-20
• Device Lot Number: 4217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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; Required Intervention
• Patient Age: 44 YR