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

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 03/01/2015

Event Type  Injury  

Event Description

It was reported that the patient complained of left shoulder and neck pain with vns stimulation on-times.The pain originated in the shoulder.Chest x-rays were ordered and the patient was referred for generator replacement.Good faith attempts for additional relevant information have been unsuccessful to date.No known surgical intervention has been performed to date.

Event Description

Clinic notes reported that at the patient's visit on (b)(6) 2015 the patient was experiencing pain with vns stimulation.As a result, vns settings were decreased.At the next appointment with neurosurgery on (b)(6) 2015, the device was disabled to assess what was causing the painful stimulation.After the device was disabled, the sternal pain resolved.No additional relevant information has been received to date.

Event Description

It was reported that the patient was referred for full vns replacement.No known surgical intervention has been performed to date.

Event Description

Generator replacement surgery occurred.The explanted device has not been received by the manufacturer to-date.

Event Description

The explanted generator was received for analysis which was completed on 02/14/2017.The device output signal was monitored for more than 24-hours in a simulated body temperature environment.Results showed no variation in the output signal and demonstrated the expected level of output current for the entire monitoring period.The diagnostics were as expected for the programmed parameters.The device performed according to functional specifications.Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

• 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: 4668220
• MDR Text Key: 22163857
• Report Number: 1644487-2015-04404
• 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,Followup,Followup,Followup,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2010
• Device Model Number: 102
• Device Lot Number: 200801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2008
• 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: 20 YR