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 Death (1802); Loss of consciousness (2418); Cognitive Changes (2551)

Event Date 01/07/2015

Event Type  Death  

Event Description

It was reported that the patient was seen by the physician on (b)(6) 2015.The vns was working fine and the physician decreased the off time from 1.8 min to 1.1 min and no other settings were changed.The patient stayed with a family member in the waiting room for an hour and tolerated the changed to the settings well.The patient went home and a few hours later, family member stated that they found him in the bathroom unresponsive.Exact cause of death is unknown; however, the physician stated she did not feel that the cause of death was due to vns.The patient underwent an autopsy but there is no ruling yet on the cause of death.It was noted that the vns device was explanted but the medical examiner¿s office keeps the device for two years.The physician later reported that the patient had concurrent illnesses of cognitive delay and psychosis.She stated it was unknown what the cause of death was and the relationship of the patient¿s death to vns.

• Brand Name: PULSE GEN MODEL 103
• 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: 4486693
• MDR Text Key: 17298936
• Report Number: 1644487-2015-03756
• 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
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2014
• Device Model Number: 103
• Device Lot Number: 202183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2012
• 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: 22 YR