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

Model Number 302-20

Device Problems Intermittent Continuity (1121); Fracture (1260); High impedance (1291); Device Displays Incorrect Message (2591)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 03/22/2016

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2016 that the patient stated she was feeling pain and vocal changes when the device was stimulating.She said this started yesterday.Md checked her vns and ran system diagnostics, getting a high lead impedance warning message.This is likely the warning from the 24 hour auto measurement since when she ran diagnostics the impedance was 4638 ohms.It was stated that the patient's impedance back in (b)(6) was 2700 ohms and the physician is concerned that the patient may have a positional lead fracture (intermittent).The device was not turned off but was lowered to settings from 2.0ma normal and 2.5 ma magnet to 1.0 ma normal and 1.5 ma magnet.The patient did not want the device disabled all the way in fear that his depression would come back so the md only lowered settings.The md referred the patient to the neurosurgeon.Surgery has not occurred to date.

Event Description

It was reported on 06/29/2016 that the patient was seen and diagnostics were within normal limits.The patient's output current had been turned down and since that time, there has been no pain or discomfort.It is likely that the patient's device has fluctuating high/intermittent impedance.

Event Description

No surgical intervention has occurred to date.

• 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: 5582953
• MDR Text Key: 43766128
• Report Number: 1644487-2016-00819
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2011
• Device Model Number: 302-20
• Device Lot Number: 200845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 04/15/2016
• Supplement Dates Manufacturer Received: Not provided; 11/09/2017
• Supplement Dates FDA Received: 07/20/2016; 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2008
• 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: 29 YR