MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Neck Pain (2433)

Event Date 05/04/2016

Event Type  Injury  

Event Description

It was reported that the patient was experiencing neck pain, discomfort, and vocal cord paralysis since the initial implant.The patient is unable to tolerate any increases in parameter settings as per the standard dosing protocol.The patient was being referred for a possible full system revision.No surgical interventions are known to have occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient underwent an ent scope where it was confirmed that she was experiencing vocal cord paralysis and shaking of the larynx.The patient was evaluated by the surgeon who reported that he believed the patient was receiving benefit from vns therapy; even though she was unable to tolerate standard dosing she was still receiving seizure control.Since the device was functioning properly and the patient was seeing benefit the surgeon did not believe it was necessary to pursue a replacement of the vns system and the patient agreed.Further follow-up with the physician found that the likely cause of the vocal cord paralysis was related to exposure to vns stimulation since the vocal cord paralysis was occurring with vns stimulations on the left side only.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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: 6447366
• MDR Text Key: 71322424
• Report Number: 1644487-2017-03521
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 103
• Device Lot Number: 202441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2013
• 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): Other; Required Intervention
• Patient Age: 50 YR