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 11/25/2013

Event Type  Death  

Manufacturer Narrative

Event Description

It was reported through an obituary the patient passed away.It was found the patient's vns was programmed off on (b)(6) 2008.Prior to being programmed off, the vns was provided therapy as intended.It is unknown if the vns was ever programmed back on.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was reported by the psychiatrist's office that the patient died of suicide.It was noted the device cannot be blamed for the patient's death.Additionally, the psychiatrist stated the vns device was not programmed back on after it was programmed off in 2008.This shows there was a 5 year gap between when the vns was programmed off and when the patient died.No vns device return or analysis is expected.

• 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: 5356930
• MDR Text Key: 35516100
• Report Number: 1644487-2016-00070
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Report Date: 12/15/2015

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: 06/27/2008
• Device Model Number: 102
• Device Lot Number: 016030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: 02/16/2016
• Supplement Dates FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2006
• 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: 76 YR