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

Model Number 304-20

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 11/06/2015

Event Type  Injury  

Event Description

It was reported that a vns patient was referred for revision surgery as the patient is experiencing discomfort in the neck area near the electrodes after the patient lifted her son.The physician stated that the device was working fine, but has turned the device off.No known surgical intervention has occurred to-date.No additional information has been received to-date.

Event Description

Follow-up to the physician's office revealed that the pain in the neck first occurred on (b)(6) 2015 and the patient's device was disabled on the same day.The patient's vns was first reduced to the lowest settings and eventually shutoff.The patient was referred to the surgeon.X-rays were reported to have been taken, however the x-rays have not been received by the manufacturer for review.

Manufacturer Narrative

Corrected data, event description: it was inadvertently reported that x-rays had been taken, when x-rays had been ordered, but have not been known to be performed to-date.

Event Description

X-rays were ordered by the physician, but are not known to have been performed to-date.

• 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: 5274947
• MDR Text Key: 32974639
• Report Number: 1644487-2015-06669
• 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,Followup
• Report Date: 11/11/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: 304-20
• Device Lot Number: 202628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2016; 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 31 YR