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

Model Number 304-20

Device Problem Output Problem (3005)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Discomfort (2330)

Event Date 10/10/2014

Event Type  Injury  

Event Description

It was reported that the patient had tolerability issues since implant with vns stimulation due to painful stimulation in the neck electrode site and dysphagia with stimulation.Patient is not able to tolerate stimulation with settings greater than 0.75 ma.Based on the adverse events, the physician suspects an lead break despite diagnostics reported to be within normal limits.Additional information was received that the patient also experienced coughing and voice alteration with stimulation.All of these adverse events were occurring since the implant of the device.Diagnostics are within normal limits and is 4246 ohms.Settings were reduced on (b)(6) 2015 for the stimulation related issues and the magnet was reported as too strong.Settings were further reduced in february and march, and the complaints above were reduced to "mild discomfort." but patient continues to experience pain in the neck with 130 us.Patient's x-ray images of the neck and chest were received.There did not appear to be any gross fractures or discontinuities or other abnormalities that might explain the painful stimulation or dysphagia with stimulation.Additional information was received that the impedance value for the patient's device was around approximately 4000 ohms.The physician worried that the potential break in the lead near generator may be causing patient's side effects.Patient's settings were lowered to frequency of 20 hz and pulse width of 130 usec as patient was unable to tolerate stimulation 30 hz and 250 usec.Patient underwent lead revision surgery on (b)(6) 2015.The explanted lead has not been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: additional information was received that the explanted lead was suspected to be discarded.Information about the product disposition was inadvertently left out from the initial mdr.Evaluation codes (refer to coding manual) conclusions, corrected data: 70.Information about the product disposition was inadvertently left out from the initial mdr.

Event Description

Information was later received that the explanted lead was suspected to be discarded.

• 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: 5243003
• MDR Text Key: 31907299
• Report Number: 1644487-2015-06536
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/29/2018
• Device Model Number: 304-20
• Device Lot Number: 203000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2014
• 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: 45 YR