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); Chemical Exposure (2570)

Event Date 07/11/2012

Event Type  Death  

Event Description

It was identified that a patient had died on (b)(6) 2012 due to 'poisoning by and exposure to other and unspecified drugs, medicaments, and biological substances, undetermined intent; poisoning by other opioids; poisoning by tricyclic and tetracyclic antidepressants; poisoning by other and unspecified antidepressants.' the relationship of the death to vns therapy is unknown.

Event Description

The patient was last seen by their physician on (b)(6) 2009.The patient had been diagnosed with bipolar ii disorder and post-traumatic stress disorder and was depressed for ">20" years.The physician did not know the cause of death.

• Brand Name: PULSE GEN MODEL 102
• 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: 4929042
• MDR Text Key: 6027311
• Report Number: 1644487-2015-05270
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,hea
• Reporter Occupation: Other
• Type of Report: Initial
• 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: 10/31/2007
• Device Model Number: 102
• Device Lot Number: 014585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2005
• 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: 49 YR