MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem Pneumonia (2011)

Event Type  Injury  

Event Description

It was reported by the patient mother that the patient had difficulty eating and drinking during vns stimulation and would aspirate his food and water.The patient was diagnosed twice with pneumonia.It was suggested the patient receive a feeding tube; however, the neurologist suggested turning the vns off during mealtimes, and this has corrected the issue to the family satisfaction.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received which noted the patient's first occurrence of pneumonia began in 2014.The exact date is unknown.The patient was admitted for pneumonia again on (b)(6) 2016.Both occurrences of pneumonia were due to continued dysphagia and aspiration difficulties with his implanted vns.This continued until the family began placing the vns magnet over the vns generator when the patient was eating.Diagnostics during the time the patient was experiencing the dysphagia and aspiration issues was not provided; however, the most recent diagnostics for the device which was implanted during this time showed results within normal limits, indicating the device was working as intended.

• Brand Name: PULSE GEN MODEL 102
• 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: 6030527
• MDR Text Key: 57481949
• Report Number: 1644487-2016-02372
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/21/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2013
• Device Model Number: 102
• Device Lot Number: 3137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2011
• 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: 22 YR