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 Complaint, Ill-Defined (2331); Depression (2361); Sleep Dysfunction (2517)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2015 note that the patient's depression has been worsening and that the vns battery is out.The patient has been experiencing sad mood, poor energy, poor sleep, decreased appetite, low self esteem, feeling of hopelessness and anhedonia.It is unknown whether or not the depression is an increase above the patient's pre-vns baseline frequency.The patient was referred for surgery.No known surgical interventions have been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

The patient received a prophylactic generator replacement on (b)(6) 2015.Pre-operative system diagnostic results were within normal limits.

• 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: 4661934
• MDR Text Key: 5734832
• Report Number: 1644487-2015-04380
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2007
• Device Model Number: 102
• Device Lot Number: 014277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2005
• 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 Age: 34 YR