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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/05/2014

Event Type  Death  

Event Description

A copy of the autopsy report was received where the cause of death was listed as atherosclerotic cardiovascular disease (hardening of the arteries of the heart) and a seizure disorder.At autopsy, there were focal areas of myocardial fibrosis indicating that the deceased had suffered multiple myocardial infarctions (heart attacks) in the remote past.The deceased also suffered from a seizure disorder which also contributed to her death.The manner of death was listed as natural.An internal sduep evaluation was performed and it was determined that the death was unlikely sudep.

Event Description

It was reported that the vns patient passed away in her sleep on (b)(6) 2014.The physician suspected sudep.The patient¿s device was not explanted prior to cremation.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3840356
• MDR Text Key: 5372129
• Report Number: 1644487-2014-01383
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2015
• Device Model Number: 103
• Device Lot Number: 202509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2013
• 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: 40 YR