MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Fibrosis (3167)

Event Date 01/01/1998

Event Type  Injury  

Event Description

A case study titled ¿optimizing outcomes in refractory childhood epilepsy with vns therapy¿ was presented which included a vns patient who was experiencing painful stimulation and choking sensations months following vns implant surgery.The patient¿s device settings were very low and not high enough to perform system diagnostics.In (b)(6) 2013, an evoked potential test was performed but no abnormalities were observed.The patient underwent generator and lead replacement surgery on (b)(6) 2014.During the procedure, the surgeon noted that the vagus nerve was located more anteromedial to the common carotid arteries than expected possibly due to the large amount of fibrosis.The surgeon did not observe any issues with the patient¿s lead but noted that the electrodes were implanted more proximal to the nerve.The patient¿s physicians determined that the patient¿s issues were due to the electrodes being implanted too high and the nerve being superficial to the larynx.It was noted that the patient had been doing well with vns following the procedure.

Manufacturer Narrative

• Brand Name: LEAD MODEL UNKNOWN
• 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: 4461163
• MDR Text Key: 5181559
• Report Number: 1644487-2015-03705
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2013
• 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: 23 YR