MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Apnea (1720); Undesired Nerve Stimulation (1980); Pain (1994); Choking (2464)

Event Date 12/05/2014

Event Type  Injury  

Event Description

Additional information was received that the patient underwent generator replacement on (b)(6) 2015.The explanted generator is suspected to have been discarded by the explanting facility and will not be returned to the manufacturer; therefore, no product analysis can be performed.

Event Description

Additional information was received that the patient¿s explanted generator will be returned to the manufacturer but the explanted product has not been received to date.

Event Description

The explanted generator was received on 03/10/2015.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.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

Clinic notes were received indicating that the vns patient was experiencing pain in the neck, throat, jugular, and chest during stimulation on-times.The patient described it as a choking feeling.It was also noted that the patient¿s apnea had worsened since vns.The physician did not decrease the patient's device settings due to potential effects of the decrease in therapy.The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 103
• 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: 4377482
• MDR Text Key: 5321372
• Report Number: 1644487-2015-03496
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2014

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: 11/30/2011
• Device Model Number: 103
• Device Lot Number: 2612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 01/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/30/2015; 03/06/2015; 04/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2010
• 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: 41 YR