MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient was being evaluated for aspiration.The patient's mother did not believe he was aspirating because he could eat and drink at home.However, the patient would not drink the barium dye for a swallow study because he did not understand that it was a medical test and did not want to drink it.The patient's mother also reported that the patient's throat was vibrating, which is why the physicians believed that the patient was aspirating.The patient had stayed in the hospital for four and a half days, but no information was available if the hospitalization was for the aspiration or swallow study.The patient's mother later reported that someone at the patient's school said that they saw the patient aspirate, so the patient was referred for the swallow study that he failed for not swallowing the barium dye.The patient's mother refused to have the patient's vns disabled during the swallow study.The physician recommended programming the device off or placing the magnet over the patient's vns during lunch, and training for the school staff was offered.No further relevant information has been received to date.

Event Description

The physician did not plan on doing any intervention for the possible aspiration and throat vibrating.The patient had never had any swallowing issues in the past, and there was no indication that he was having any issues with his vns.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 5895404
• MDR Text Key: 52722395
• Report Number: 1644487-2016-01905
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2017
• Device Model Number: 106
• Device Lot Number: 4593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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): Hospitalization
• Patient Age: 16 YR