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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Discomfort (2330)

Event Date 08/01/2015

Event Type  Death  

Manufacturer Narrative

Event Description

It was reported that a vns patient was deceased.Follow-up to the patient's long-term group care facility revealed that the cause of death was cardiac arrest.It was reported that in the week prior to the patient's passing the patient indicated abdominal discomfort and was evaluated by the staff.A physical examination on (b)(6) 2015 revealed the patient was alert, hydrated, and not in distress.The patient's lungs were noted to be clear of congestion.An ekg was performed and detected no murmur, no arrhythmia, and indicated normal function.Of the heart the patient was then seen by the treating neurologist on (b)(6) 2015 and the vns was checked.The patient experienced the cardiac arrest on (b)(6) 2015 and was taken to the nearest hospital.It was stated attempts to resuscitate were performed, but were unsuccessful and the patient was pronounced dead at arrival to the hospital.The hospital and the long-term group care facility declined to perform an autopsy.It was reported that as there was no clinical evidence of the underlying cause of cardiac arrest, sudep was possible.No additional relevant information has been received to-date.

Event Description

Follow-up to the vns physician at the patient's group home revealed that the patient had died from a sudden cardiopulmonary event.Diagnostics performed on (b)(6) 2015 were within normal limits.

• 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: 5462820
• MDR Text Key: 39103316
• Report Number: 1644487-2016-00419
• 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: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

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: 10/31/2015
• Device Model Number: 103
• Device Lot Number: 202699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2013
• 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): Death
• Patient Age: 23 YR