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

Model Number 102

Device Problem Battery Problem (2885)

Patient Problem Vomiting (2144)

Event Date 09/01/2015

Event Type  Injury  

Event Description

It was reported that the patient was experiencing an increase in depression along with several manic episodes over the past 7-8 months and that currently there was no physician overseeing the patient's vns settings.The patient was then admitted to the hospital several times due to mental breakdowns.The patient's primary care physician expressed concern about the generator's battery life due to the age of the device.Further follow-up found that during one of the patient's admittance to the hospital, a neurosurgeon interrogated the device and found that the device was programmed to deliver 0.5 ma of output current.However when he attempted to run a system diagnostic test at 1 ma of output current, the patient began vomiting.No surgical interventions are known to have occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient underwent generator replacement surgery.The explanted generator was discarded after the surgery.Therefore product analysis cannot be completed.

• 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: 5718578
• MDR Text Key: 47197244
• Report Number: 1644487-2016-01311
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2008
• Device Model Number: 102
• Device Lot Number: 016389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2006
• 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): Hospitalization
• Patient Age: 44 YR