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

Model Number 106

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

Patient Problems Cardiac Arrest (1762); Death (1802); Seizures (2063); Malaise (2359)

Event Date 10/28/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was hospitalized due to feeling sick and having a few seizures, which were not alleged to be related to the patient's vns.The patient was intubated and experienced cardiac arrest while in the emergency department.The patient was then transferred to the icu, and a brain mri was scheduled.It was later reported that the patient was placed on life support on (b)(6) 2016 and was deemed brain dead.The patient passed away on (b)(6) 2016, and the device was not explanted.Attempts for further information were unsuccessful to date.

Event Description

The physician provided the patient's device settings, but diagnostic results were not provided.No further relevant information has been received to date.

Event Description

The death summary from the patient's hospitalization was provided.The patient presented at the emergency room after he had a seizure, administered ativan, and was taken to the hospital by emergency medical services.The patient had a history of seizure disorders and developmental delay.The patient also had a urinary tract infection.The initial assessment upon the patient's arrival was encephalopathy postanoxic, postictal cardiac arrest, pulseless electrical activity (pea), postanoxic myoclonus, status epilepticus, acute respiratory failure, and elevated hepatic enzymes.The patient was given antiepileptic medications while in the hospital.The patient also had evidence of kidney injury, and the assessment was acute kidney injury, metabolic acidosis, and anemia.The patient was in the icu, and the assessment was that the patient had respiratory to cardiac arrest, secondary to seizure and ativan administration.A chest x-ray revealed a left lower lobe infiltrate and presumptive pneumonia.Subsequent to this, the patient remained in an anoxic state and ventilator dependent.An mri was performed, which was consistent with anoxic brain injury.The patient's family and physicians decided to remove the patient from life support, and the patient passed away due to respiratory failure secondary to anoxic encephalopathy.

• 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: 6122170
• MDR Text Key: 60716617
• Report Number: 1644487-2016-02715
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/27/2018
• Device Model Number: 106
• Device Lot Number: 203712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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): Death
• Patient Age: 25 YR