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

Model Number 106

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pneumonia (2011); Seizures (2063); Vomiting (2144)

Event Date 11/02/2016

Event Type  Injury  

Event Description

The patient underwent generator and lead replacement on (b)(6) 2016.The surgery was reported to have gone well with no issues.On (b)(6) 2016 the patient vomited and then vomited again the next day.On the evening of (b)(6) 2016, the patient began to have seizures and was admitted to the icu.The patient then developed pneumonia and the pulmonologist theorized the patient might have aspiration pneumonia, but this has not been confirmed.The generator is currently programmed off and has not been turned on since the surgery.Attempts at additional information have been made, but no additional relevant information has been received to date.

Event Description

Per the physician, the aspiration was the cause of the patient's vomiting and pneumonia.The physician could not be certain that the aspiration occurred during the patient's recent vns surgery.No additional 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: 6141156
• MDR Text Key: 61339507
• Report Number: 1644487-2016-02769
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 43 YR