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

Model Number 103

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

Patient Problems Cardiac Arrest (1762); Death (1802); Seizures (2063); Sepsis (2067)

Event Type  Death  

Event Description

Additional information was received from the physician stating that the vns patient¿s death was unrelated to vns.The patient achieved seizure reduction with vns and was receiving therapy at the time of death.Diagnostic results showed normal device function at the patient last office visit on (b)(6) 2014.Based on the available information about the patient¿s death, an internal classification has determined that the death was unlikely sudep.

Event Description

It was reported that the vns patient passed away.It was reported that the death certificate lists the cause of death as cardiac arrest, sepsis secondary to peritonitis.A significant condition was listed as seizure disorder.The relationship of the vns to the cause of death is unknown.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

• 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: 4381874
• MDR Text Key: 5344869
• Report Number: 1644487-2015-03519
• 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: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2011
• Device Model Number: 103
• Device Lot Number: 201020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2009
• 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