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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/09/2012

Event Type  Death  

Event Description

It was reported by a company representative that a vns patient was deceased.The company representative discovered this after an obituary search after the treating psychiatrist indicated the patient was lost-to follow-up and did not know who was treating the patient.The obituary indicated that the patient died following a lengthy illness.An estimate of battery life with programming data available in the manufacturer's database indicates 0.0 years until near end of service, and the last available diagnostics in the manufacturer's programming history database showed the device was within normal limits on (b)(6) 2010.No additional relevant information has been received to-date.

Event Description

The physician later reported the cause of death to be due to terminal cancer unrelated to vns.Correspondence from the state provided the death certificate for the patient, which indicated the specific contributing factors of death as st segment myocardial infarction due to intracranial hemorrhage and aspiration pneumonia as a result of an underlying cause of acute renal failure.An autopsy was not performed and it was stated they were not aware if the device had been removed as a result.The manner of death was classified as natural.

• 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: 5245212
• MDR Text Key: 31966204
• Report Number: 1644487-2015-06527
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

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: 04/30/2007
• Device Model Number: 102
• Device Lot Number: 012991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2005
• 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: 57 YR