MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem Human-Device Interface Problem (2949)

Patient Problems Dyspnea (1816); Therapeutic Response, Decreased (2271); Reaction (2414); Choking (2464)

Event Date 10/06/2015

Event Type  malfunction  

Event Description

A patient reported to their physician that he could no longer feel the vns activating.The physician increased the normal output current stimulation from 2.00ma up to 2.25ma.The patient had an adverse reaction to this increase causing him to cough and choke.The physician then reduced settings until the patient could tolerate them.The patient later reported on a follow-up visit on (b)(6) 2015 that he had previously experienced a fall and chest trauma and that he could feel the vns activating at the generator site.Normal mode diagnostics indicated an impedance reading of lead impedance=ok, dcdc=0, near end of service=no.The physician suspected the lead had a short circuit based on the dcdc value of 0, although this result was on normal mode diagnostics rather than systems diagnostics.The device was disabled on (b)(6) 2015, and it was indicated that the patient wants to try medicine alone.X-rays were ordered by the physician, but have not been received by the manufacturer for review.A review of the available programming history in the manufacturer's database showed the last normal mode diagnostics on (b)(6) 2014 to have an impedance value of dcdc=4.Additional relevant information has not been received to-date.

Event Description

Follow-up to the physician¿s office revealed that the patient had gained 15 kilograms since deactivation of vns.It was reported that the patient was programmed to 0.75ma, which was where the coughing and choking stopped, prior to the device being disabled.There had been no change in quantity of seizures or stability since the device was disabled.The patient¿s family was anxious to remove the device as it was believed the device is no longer needed.The weight gain was considered positive for the patient.An increase in cognition was reported since the device was disabled.The x-rays taken did not show any device issue.Diagnostics were performed with the patient in multiple positions to rule out an issue related to the position of the device and the diagnostics were reported to be the same in multiple positions.No known surgery has occurred to-date.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 5232917
• MDR Text Key: 31748398
• Report Number: 1644487-2015-06476
• 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: 10/20/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2000
• Device Model Number: 300-20
• Device Lot Number: 16992C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/1998
• 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: 43 YR