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

Model Number 304-20

Device Problem Extrusion (2934)

Patient Problem Erosion (1750)

Event Date 07/14/2015

Event Type  Injury  

Event Description

It was reported that the patient's lead site was eroding through the skin so the physician explanted both the generator and the lead.It was reported that the patient would be reimplanted in 6-8 weeks.No known surgery has been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Follow-up was performed with the neurosurgeon's physician assistant.The patient went to the er on (b)(6) 2015 because 2 weeks prior, her mother noticed what appeared to be an infected stitch.They removed the stitch in the er and the lead wires became exposed.They presumed that the "entire system" was infected and decided to remove the entire system.Cultures were positive for (b)(6).Interventions were removal of the vns system and antibiotics for 14 days.Interventions were taken to preclude serious injury.Patient was seen for follow-up on (b)(6) 2015 and was healing well.The events are thought to be related to the surgery.There is a plan to re-implant.A review of manufacturing records showed that both the lead and generator were sterilized prior to distribution.A company representative received information from another physician assistant, who reported that this was a case where the deep stitch was not tight enough.The stitch comes loose and the patient grabs at it.She believed the surgery was the reason for the stitch coming loose.

Event Description

Patient underwent full revision of lead and generator on (b)(6 2015.

• 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: 4973866
• MDR Text Key: 20451730
• Report Number: 1644487-2015-05455
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Model Number: 304-20
• Device Lot Number: 202808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2014
• 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): Required Intervention
• Patient Age: 14 YR