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

Model Number 102

Device Problem Battery Problem (2885)

Patient Problem Depression (2361)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient had been experiencing an increase in depression and auras.The patient stated that she was no longer able to perceive stimulation on-times from the device.The patient mentioned that the device was last check by the physician prior to (b)(6) 2014 and the device showed a low battery condition.Attempts for additional relevant information have been unsuccessful to date.

Event Description

No known surgical interventions have occurred to date.A battery life calculation using the available programming history showed approximately 1.5 years remaining.

Event Description

It was reported that the patient's generator was replaced due to battery depletion.Return of the suspect product is not expected.No further relevant information has been received to date.

• 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: 4746473
• MDR Text Key: 5827504
• Report Number: 1644487-2015-04611
• 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: Consumer,Company Representative,company representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2006
• Device Model Number: 102
• Device Lot Number: 011767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2005
• 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: 59 YR