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

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Seizures (2063); Seizures, Grand-Mal (2168); Therapeutic Response, Decreased (2271)

Event Date 10/01/2014

Event Type  Injury  

Manufacturer Narrative

Event Description

In clinic notes dated (b)(6) 2015, it was reported that the patient was experiencing breakthrough seizures over the last year, and had a grand mal after "behavioral arrest" which has been identified from the patient history as her normal seizure type.The patient's friend who was at the visit noted that swiping the magnet appeared to make the seizure almost "worse".The notes reported that prior to these events she was seizure/spell free for 3 months.The vns was interrogated and the battery was indicated at <10%.No medication changes were made.The patient was referred for generator replacement surgery.No known surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

Follow-up from the physician's office was received.It was reported that the increase in seizures were above the pre-vns baseline.No device diagnostics were performed at the last check-up.The increase in seizures was stated to be due to battery end-of-life.Magnet mode diagnostics were not performed.The issue regarding the report of magnet mode making seizures worse was stated to be due to battery end-of life as well.

• 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: 5206766
• MDR Text Key: 30582302
• Report Number: 1644487-2015-06349
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2013
• Device Model Number: 103
• Device Lot Number: 2967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2011
• 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: 31 YR