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

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/05/2015

Event Type  malfunction  

Event Description

It was reported that the patient was requesting explant of her vns device because she believed it was no longer working.No additional relevant information ahs been received to date.

Event Description

Additional information was received that the patient is still reporting the device is not working and also that it is causing pain.Available programming history for this patient was reviewed and revealed normal diagnostics up through (b)(6) 2007.A battery life calculation was performed with the available programming history.The result revealed 2.0 years remaining until near end of service flag = yes.It was reported that the patient believes that some other external device shorted the vns system, although clarification on this point could not be obtained.When the patient's vns generator was interrogated, it showed that the device was set to 0.0ma output current.No additional relevant information has been obtained to date.No known surgical interventions have occurred 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: 4869794
• MDR Text Key: 6043023
• Report Number: 1644487-2015-05015
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/27/2007
• Device Model Number: 102
• Device Lot Number: 12240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2005
• 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): Required Intervention
• Patient Age: 69 YR