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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2014 note that the patient's seizures are fifteen times a month and last two to three minutes.It was noted that the patient experienced an increase in seizures in (b)(6) 2013 with two seizures for over a week.The physician increased the device output current to 2ma and the patient became seizure free again.The notes indicate that the patient has experienced more frequent seizures that have changed in character.It was noted that there have been no recent medication changes.Clinic notes dated (b)(6) 2014 note that the patient's seizures are every other day and are shorter and less impairing.The assessment notes that vns placement and rufinamide have helped seizures, but she continues to have approximately 8 complex partial seizures per month.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Additional clinic notes were received.The clinic notes report that shortly after the vns surgery (in (b)(6) 2013), the patient had a different seizure presentation.Patient stares and patient¿s head will often slump down.No arm movement was observed.These were happening once per day at various times, lasting about 3 min each time, and started shortly after her surgery.The clinic notes also report that from (b)(6) 2013, the vns current was at 1.5ma and the patient had several auras but no seizures.Then the vns was increased to 1.75ma on (b)(6) 2013 and the patient had 1-2 seizures per day from (b)(6) 2013 so the vns was decreased back to 1.5 per the parent¿s requests.Additional information was received from the neurologist that there were no medication changes that could have caused or contributed to the new seizure type.Per the physician, the new seizure type is not likely related to vns therapy.

• 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: 3790928
• MDR Text Key: 4441151
• Report Number: 1644487-2014-01199
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2014
• Device Model Number: 102
• Device Lot Number: 202207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2012
• 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: 13 YR