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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problem Seizures (2063)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported by the patient's grandmother that the patient has been experiencing an increase in seizures when the vns settings are titrated.The grandmother also reported that she told the physician of the increase in seizures, and in response, the physician increased the patient's medications and vns settings in the same visit.It was reported by the grandmother that the patient was only on 2 medications prior to vns therapy and now the patient is on 4 medications.It was noted the patient was seizure free for a few months following the implant and initial dosing of the vns system, until the last few months.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

It was reported by the physician that the patient's reported increase in seizures is not believed to be related to vns.The increase in seizures was noted to be above pre-vns levels.It was also reported the patient has had several new medications added that could have caused or contributed to the reported increase in seizures.

Manufacturer Narrative

(b)(4).

• Brand Name: PULSE GEN MODEL 103
• 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: 5105185
• MDR Text Key: 26807610
• Report Number: 1644487-2015-05902
• 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: company representative,health
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 08/31/2015

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: 09/15/2016
• Device Model Number: 103
• Device Lot Number: 203154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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): Other
• Patient Age: 23 YR