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 Problems Death (1802); Cognitive Changes (2551)

Event Date 10/19/2013

Event Type  Death  

Event Description

It was reported that the vns study patient passed away on (b)(6) 2013.The national death index from the cdc website listed the patient's cause of death as malignant neoplasm of bronchus or lung secondary to unspecified mental and behavioral disorder due to use of tobacco.The relationship of the death to vns is unknown.No further information relevant to the patient's death has been received to date.Based on the available information about the patient¿s death, an internal classification has determined that the death was unlikely sudep. .

Event Description

The initial mdr reported for this event was submitted in error.There is no direct relationship suspected between the death due to lung cancer and vns.

Manufacturer Narrative

The previously submitted mdr was reported in error.There is no direct relationship suspected between the death due to lung cancer and vns.

• Brand Name: PULSE GEN MODEL 102
• 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: 4925839
• MDR Text Key: 6434908
• Report Number: 1644487-2015-05262
• 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: Other,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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: 03/31/2010
• Device Model Number: 102
• Device Lot Number: 200784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/26/2015
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2008
• 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: 58 YR