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 11/01/2014

Event Type  Injury  

Event Description

It was reported that the vns patient had been experiencing nocturnal seizures for the past two weeks.The patient stated that the seizures were convulsions and did not cause her to lose awareness.The patient also reported experiencing a change in seizure pattern; she stated she began having other feelings ¿inside¿ along with automatisms.It was noted that the magnet mode stimulation had been helpful in aborting the patient¿s seizures.The patient was instructed to activate magnet mode stimulation a few times before bedtime or during the day.The patient denied any life stressors but believed her ipad may have been triggering her seizures.The patient was instructed to visit with the following physician.Attempts for additional relevant information will be made.

Event Description

Additional information was received stating that the vns patient had been experiencing an increase in seizures and a new seizure type in november and (b)(6) of 2014.The seizures were attributed to stress during the holiday season.The patient was seen on (b)(6) 2015 and was doing well.The seizures had resolved and the patient¿s device was functioning well.There was no mention of potential issues with her ipad during the office visit and no further information was obtained as the patient was doing well.

• 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: 4377912
• MDR Text Key: 5286479
• Report Number: 1644487-2015-03511
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,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: 12/31/2013
• Device Model Number: 103
• Device Lot Number: 3222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 01/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2011
• 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: 53 YR