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

Model Number 103

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

Patient Problem Seizures (2063)

Event Date 09/07/2015

Event Type  malfunction  

Event Description

It was reported by the patient that he had a seizure and used the magnet, but he did not feel the vns stimulate.It was noted the seizure lasted about 10 minutes, but he does not recall his recovery time.The patient also reported his seizure activity has increased recently.It is unknown if the reported increase in seizures is above pre-vns levels.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

It was reported by the patient on (b)(6) 2015, during a check in call by the company representative, that the patient was in the emergency room and that he came to the hospital two days ago.No additional information was provided.It was later reported by the patient that his physician who monitors his diabetes told the patient that it is a possibility that his medications for diabetes are causing the seizures, but the physician does not know which one.The patient has not yet followed up with his following neurologist.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was reported by the patient that he could be doing better, but he lost his vns magnets.The company representatives stated she would ship a patient magnet kit to the patient.The patient also noted he had a few "attacks" a few weeks ago and an eeg was performed.The patient has yet to re-establish care with his following neurologist and he was encouraged by the company representative to make an appointment as he needs to be followed by a physician.Attempts for additional information have been unsuccessful to date.

• 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: 5145443
• MDR Text Key: 28506725
• Report Number: 1644487-2015-06097
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: 103
• Device Lot Number: 202771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2014
• 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 Age: 41 YR