MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 101; GENERATOR

Model Number 101

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/24/2016

Event Type  Death  

Event Description

It was reported that the patient passed away the week of (b)(6) 2016.The patient's vns had died and was no longer delivering stimulation at the time of death.On (b)(6) 2016, the patient's caretaker said the patient was on life support and didn't know if the patient would be able to handle any surgery.Per a manual battery life calculation, it is likely the reports that the device was not working at the time of death were correct.Per a sudep evaluation, this patient experienced possible sudep attempts to find an online obituary for the deceased were made, but no relevant information has been found to date.No additional relevant information has been received to date.The generator has not been received to date.

• Brand Name: PULSE GEN MODEL 101
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6119312
• MDR Text Key: 60619827
• Report Number: 1644487-2016-02703
• 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,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/01/2016

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: 09/30/2001
• Device Model Number: 101
• Device Lot Number: 37270C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2000
• 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: 21 YR