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

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Seizures (2063)

Event Date 07/28/2014

Event Type  Injury  

Event Description

Clinic notes were received indicating that the vns patient had been experiencing an increase in seizures for the past three weeks prior to his office visit on (b)(6) 2014.The patient also began having several generalized tonic-clonic seizures which have not been observed while the patient has had vns.Following vns, the patient has had three primary seizure types: (1) tonic movements of the arms with head deviation to the left, (2) chewing automatisms with head bobbing of the head and neck, and (3) facial grimacing.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.The patient was referred for surgery but no known surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Analysis was completed on the explanted generator.There were no performance or any other type of adverse conditions found with the pulse generator.The device output signal was monitored for more than 24-hours, 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.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Event Description

An implant card was received and reported that the reason for generator replacement was battery depletion.

Manufacturer Narrative

Review of the available programming and diagnostic history.

Event Description

The patient had generator replacement on (b)(6) 2015.The generator was received by the manufacturer for analysis.However, analysis has not been completed to date.

• 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: 4184637
• MDR Text Key: 5089583
• Report Number: 1644487-2014-02752
• 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,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• 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: 2624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2010
• 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: 22 YR