MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Chest Pain (1776); Headache (1880); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Response, Decreased (2271); Neck Pain (2433)

Event Date 08/01/2014

Event Type  malfunction  

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

On (b)(6) 2015, patient's vns device was disabled due to painful stimulation and lack of efficacy.Patient experienced headache, pain in the chest, neck and radiating pain in the left ear with stimulation.Systems diagnostics were performed and high impedance was observed.On (b)(6) 2015, the patient came back and wanted the device turned on.The patient had reported initially that she did not receive much benefit from vns.Once the device was disabled, the patient returned and said that she did receive benefit from it and therefore the vns was turned back on.Patient was referred for x-rays but it is unknown of the device was turned on again.Patient had previously reported headaches, painful stimulation in the neck and face and pulsating at the generator site since (b)(6) 2014.No known surgical interventions have 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: 4957000
• MDR Text Key: 23239019
• Report Number: 1644487-2015-05389
• Device Sequence Number: 1
• Product Code: MUZ
• 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,consum
• Reporter Occupation: Other
• Report Date: 07/13/2015

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: 02/01/2009
• Device Model Number: 302-20
• Device Lot Number: 1556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2006
• 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: 37 YR