MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Application Program Problem: Power Calculation Error (1473); Battery Problem (2885)

Patient Problem Death (1802)

Event Date 08/30/2015

Event Type  Death  

Event Description

On (b)(6) 2016 it was reported that a patient passed away on (b)(6) 2015.The cause of death is unknown.A battery life calculation indicated that the patient's generator should have been working at the time of their death since nearly a year later there was still 0.3 years remaining.No further relevant information has been received to date.

Event Description

The death certificate was received on 10/03/2016.The patient's death discharge summary from the hospital, he passed away in states that the patient has had several hospital admissions for his chronic inflammatory demyelinating polyneuritis and was recently diagnosed with b-cell lymphoma and started on chemotherapy.He was able to be stabilized and discharged home.However, he returned to the hospital on (b)(6) 2015 due to fever.Patient was admitted to icu and given antibiotics for sepsis and supportive care.Patient had issues with tachycardia and chronic respiratory failure likely due to the chemotherapy.Patient continued to show evidence of failure to thrive and eventually passed.The cause of death was sepsis and chronic inflammatory demyelinating polyneuritis along with heart failure.

• Brand Name: PULSE GEN MODEL 103
• 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: 5959999
• MDR Text Key: 55038378
• Report Number: 1644487-2016-02122
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: 103
• Device Lot Number: 202364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• 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: 39 YR