MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problems Loose or Intermittent Connection (1371); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported in clinic notes dated (b)(6) 2015 that the physician identified a mass on the left lateral portion of the patient's neck.At a follow-up visit on (b)(6) 2016 the patient was experiencing painful stimulation in the neck and the physician believed one of the vns electrodes on the nerve had become loose.It was reported that the vns generator settings were then adjusted in response to the pain.The physician referred the patient for generator replacement due to the painful stimulation, however no surgical interventions are known to have occurred to date.Attempts to obtain additional relevant information have been unsuccessful 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: 5597668
• MDR Text Key: 44222007
• Report Number: 1644487-2016-00858
• 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: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/21/2019
• Device Model Number: 304-20
• Device Lot Number: 4220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• 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: 24 YR