MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

Report received that a patient felt the vns caused her to have an increase in seizures.The available programming history showed the only system diagnostic taken was on the day of implant.The results indicated the system was functioning normally.Further information was received from one of the patient's more recent neurologists that the vns was checked since the allegation was made and showed normal functionality.He was reportedly not aware of the patient having an increase in seizures.No further relevant information has been received to date.

Event Description

Further information was received from the patient's current neurologist.The neurologist stated that she only saw the patient one time since the initial report of increased seizures.She reported that her impression was that the patient was non-compliant with her medications and speculated that the increase in seizures was due to the non-compliance.She stated that she did not believe the vns caused the increase in seizures.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 6963638
• MDR Text Key: 90189493
• Report Number: 1644487-2017-04648
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/23/2015
• Device Model Number: 105
• Device Lot Number: 202832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 22 YR