MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Insufficient Information (3190)

Patient Problems Aspiration/Inhalation (1725); Death (1802)

Event Date 12/14/2012

Event Type  Death  

Event Description

It was reported that the vns patient passed away on (b)(6) 2012.The cause of death is believed to be due to aspiration.The relationship between the death and vns is unknown.No further information relevant to the patient¿s death has been received to date.

Event Description

A copy of the death certificate was received which indicated that cause of death as acute respiratory distress syndrome due to aspiration pneumonia.Follow-up with the physician indicated that the patient¿s death was not related to vns.The patient achieved seizure reduction with vns and was receiving therapy at the time of death.The patient was compliant with her medications.Based on the available information about the patient¿s death, an internal classification has determined that the death was unlikely sudep.

• Brand Name: PULSE GEN MODEL 104
• 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: 4163522
• MDR Text Key: 4867765
• Report Number: 1644487-2014-02637
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2012
• Device Model Number: 104
• Device Lot Number: 2656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2010
• 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: 27 YR