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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 08/03/2015

Event Type  malfunction  

Event Description

Clinic notes were received indicating that the vns patient's device showed a high impedance condition during an office visit on (b)(6) 2015.It was noted that the patient's seizures were fairly controlled at that time.The patient returned to the office on (b)(6) 2015.The patient's mother indicated that the patient's seizures had gotten worse.The patient's medication was subsequently increased.The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description

Additional information was received stating that during generator and lead replacement surgery on (b)(4) 2015, the surgeon was unable to complete the procedure due to fibrosis around the electrode site and the patient's anatomy.The replacement generator was tested to the existing lead and diagnostic results continued to show a high impedance condition.The surgeon opened up the neck incision site but was unable to explant the lead electrodes from the patient's vagus nerve due to fibrosis.The surgeon noted that the patient's vagus nerve was "tangled and bundled with other nerves" above the electrode site and was unable to locate an implant location for the replacement lead.The patient's generator was explanted along with a portion the lead.The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.The patient has not been re-implanted to date.

Event Description

Additional information was received stating that the patient was re-implanted on (b)(6) 2015.The generator and lead were placed on the right side of the patient's chest and vagus nerve.

• 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: 5104713
• MDR Text Key: 26960658
• Report Number: 1644487-2015-05901
• 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: Physician
• Type of Report: Followup,Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2010
• Device Model Number: 302-20
• Device Lot Number: 200675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2007
• 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: 22 YR