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); Seizures (2063)

Event Date 12/09/2010

Event Type  Death  

Event Description

Additional information was received indicating that the vns patient¿s device was not explanted after passing away.Attempts for additional relevant information were made but have been unsuccessful to date.

Event Description

A copy the death certificate was received where it states that the immediate cause of death was probable cardiac dysrhythmia due to angiomyolipomas of the heart in association with tuberous sclerosis.An autopsy was performed.

Manufacturer Narrative

Cyberonics, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

Event Description

It was reported that the vns patient passed away from status epilepticus.The patient¿s obituary stated that the patient died in the hospital on 12/09/2010 and faced lifelong medical challenges of tuberous sclerosis.Attempts for additional relevant information were made but have been unsuccessful to date.

• 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: 3715018
• MDR Text Key: 4383065
• Report Number: 1644487-2014-00839
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/05/2014

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: 02/28/2005
• Device Model Number: 102
• Device Lot Number: 8521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 03/31/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/09/2014; 06/20/2014; 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2003
• 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: 29 YR