MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Death (1802)

Event Date 10/15/2014

Event Type  Death  

Manufacturer Narrative

Device evaluated by manufacturer, additional information: device evaluation is not required because there is no suspected relationship of the death to the vns device.

Event Description

It was reported that a patient had passed away due to vomiting and suffering from aspiration.The patient suffered a severe drug-resistant epileptic encephalopathy.Additional information was received from the patient's physician indicating that the death was not related to vns, that the patient had responded to vns therapy and experienced a reduction in seizures as a result, and the patient was receiving vns therapy at the time of the death.The patient's device was not explanted and no autopsy was performed.The patient did not have a history of drug or alcohol abuse and had no history of cardiac or respiratory problems.Information was later received via an article entitled "adverse effects and surgical complications in pediatric patients undergoing vagal nerve stimulation for drug-resistant epilepsy" where the physician indicated that the patient had passed away due to sudep.

• Brand Name: PULSE GEN MODEL 103
• 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: 6420763
• MDR Text Key: 70444730
• Report Number: 1644487-2017-03437
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: 103
• Device Lot Number: 3836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2014
• 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: 2 YR