MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Asthma (1726); Atherosclerosis (1728); Death (1802); Seizures (2063); Depression (2361)

Event Date 08/04/2006

Event Type  Death  

Manufacturer Narrative

Event Description

It was reported that the patient passed away on (b)(6) 2016.She was found deceased in her home.The physician reported that the patient had cps and gtc seizures along with morbid obesity and depression.The patient was presumably seizure free, according to the physician's report.An autopsy was not performed, but the generator and lead were explanted and discarded.The patient's last visit to her physician was on (b)(6) 2006, and the patient was receiving vns therapy at the time of death to the physician's knowledge.The patient was on topimate and lamotrigine at the time of death.The relationship of the death and vns was unknown since the cause of death was unknown, but the physician did not attribute the death to vns.Additional information was received from the national death index.The cause of death was: major cardiovascular disease, generalized and unspecified atherosclerosis, other obesity, unspecified depressive episode, unspecified epilepsy, unspecified asthma, and unspecified arthrosis.A sudep (sudden unexpected death in epilepsy patients) evaluation was performed based on information from the national death index, and the death was determined to be probable sudep.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5983626
• MDR Text Key: 55824662
• Report Number: 1644487-2016-02222
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2007
• Device Model Number: 102
• Device Lot Number: 013177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2005
• 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: 47 YR