MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem Death (1802)

Event Date 08/31/2012

Event Type  Death  

Event Description

The article "long-term seizure and psychosocial outcomes of vagus nerve stimulation for intractable epilepsy" mentioned that 15 of the vns patients implanted at a certain hospital between 1997 and 2013 that the researchers attempted to contact were found to be deceased.This report will house one of 5 deaths of the known deceased patients that fit the criteria.The patient died on (b)(6) 2012 due to unknown reasons.Diagnostic results did not indicate any device malfunction.The relationship of the death to vns is unknown.Attempts for further information have been unsuccessful to date.The mfr.Report #s of the five deaths of known deceased patients are: 1644487-2015-06606, 1644487-2015-06607, 1644487-2015-06608, 1644487-2015-06609, 1644487-2015-06610.

Manufacturer Narrative

Relevant tests/laboratory data, corrected data: initial report inadvertently listed the incorrect date of system diagnostic results.Implant date, corrected data: initial report inadvertently listed the incorrect implant date.

Event Description

According to the patient's autopsy report, the patient died at home due to epileptic seizure disorder.Other pathological diagnoses were obesity, hypertensive heart disease, and lymphocytic thyroiditis.The patient had electrocardiograph pads on his left arm and both legs, had a bite on his tongue, and had multiple anti-epileptic drugs in his system at the time of death.The relationship of the death to vns is unknown.

• Brand Name: PULSE GEN MODEL 102
• 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: 5256305
• MDR Text Key: 32342956
• Report Number: 1644487-2015-06608
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2006
• Device Model Number: 102
• Device Lot Number: 010436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2004
• 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: 18 YR