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

Model Number 102R

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

Patient Problems Death (1802); Pneumonia (2011); Sepsis (2067)

Event Date 02/11/2013

Event Type  Death  

Event Description

It was reported that the vns patient passed away on (b)(6) 2013.No autopsy was performed and the patient¿s device was not explanted.The believed cause of death was listed as pneumonia, sepsis question of lung cancer.It was noted that the patient achieved seizure reduction with vns; however, the relationship between the death and vns is unknown.Based on the available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

• Brand Name: PULSE GEN MODEL 102R
• 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: 4278067
• MDR Text Key: 22159362
• Report Number: 1644487-2014-03140
• 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: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2011
• Device Model Number: 102R
• Device Lot Number: 201274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2009
• 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
• Patient Age: 54 YR