MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Nausea (1970); Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 02/01/2016

Event Type  malfunction  

Event Description

It was reported through clinic notes that the patient had two lumps on his neck and the vns lead was protruding.At the same time, he was experiencing painful stimulation along with muscle spasms and dysphagia.In addition when the patient attempted to swipe his vns magnet, he became nauseated.His physician then referred him to a surgeon for evaluation due to a suspicion that his vns lead had become loose.Further follow-up with the physician found that she did not believe the lead was coming off the nerve however she did think it was displaced.The physician stated that she did not run a system diagnostics tests because the vns stimulation was already causing the patient a severe amount of pain.The reported symptoms began within the last several months.The physician did not know why these symptoms were occurring which is why the patient was referred for further evaluation by a surgeon.Attempts to obtain additional relevant information have been unsuccessful to date.No known surgical interventions have been performed to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5630792
• MDR Text Key: 45408160
• Report Number: 1644487-2016-00948
• 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
• Report Date: 04/07/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 304-20
• Device Lot Number: 202191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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: 25 YR