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

Model Number 102

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Depression (2361)

Event Date 08/01/2014

Event Type  Injury  

Event Description

The patient underwent a prophylactic generator replacement on (b)(6) 2015.Information from the patient's nurse was received that state that the patient's vns device had a dead battery and the increase in depression is attributed to the dead battery.The facility could not provide pre-vns baseline levels of depression for this patient since they have only seen her once.No causal or contributory programming or medication changes or other external factors preceded the onset of the increase in depression.Attempts for product return for analysis have been made, but the product has not been received to date.

Event Description

It was reported that the patient has experienced a drastic increase in depression.Clinic notes dated (b)(6) 2014 note that the patient believes the generator battery is dead because she no longer feels device stimulation and has experienced an increase in depression over the past few months.The notes indicate that the device was interrogated and settings obtained, but no battery status was noted.

Event Description

The model 102 generator was returned for analysis on 01/22/2015.Product analysis for the device was completed and approved on (b)(6) 2015.In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The generator performed according to functional specifications.During the product analysis there were no anomalies found with the pulse generator.

Manufacturer Narrative

Device available for evaluation, corrected data: yes, returned 01/22/2015.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4326716
• MDR Text Key: 5310375
• Report Number: 1644487-2014-03300
• 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,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2007
• Device Model Number: 102
• Device Lot Number: 012704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/22/2015; 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2005
• 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: 56 YR