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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2015

Event Type  malfunction  

Event Description

It was reported by the nurse that high impedance was observed on the patient's vns.The nurse stated that the patient has responded well to vns and he isn't in any pain or discomfort and that the vns has been effective for the patient at low settings.The physician decided to leave the patient's device programmed on as the patient seemed to still be gaining benefit from the vns and was not experiencing any adverse events.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported x-rays were ordered due to the high impedance; however, the x-rays were unable to be released to the manufacturer for review.Attempts for additional relevant information have been unsuccessful.

Event Description

Product information and programming history data became available.X-rays were taken but a lead break was not identified.The output is set at 0.50 ma and the patient is seizure free.As the device does not cause the patient any harm, the device was not disabled.

• 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: 6252863
• MDR Text Key: 64911196
• Report Number: 1644487-2017-03034
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 302-20
• Device Lot Number: 202399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2013
• 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 Age: 28 YR