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

Event Date 05/01/2014

Event Type  Injury  

Event Description

The patient had a follow-up appointment at which time the medications were adjusted, in addition to the magnet off time from 5 minutes to 3 minutes.Diagnostics were performed to check the device function and no anomalies were noted.The group staff was re-educated on magnet usage.

Event Description

The physician¿s office reported that after the patient was started back on medication, the patient has not been herself and had increased seizures.There are a lot of health issues.When the vns was checked previously, all diagnostics were okay.

Event Description

It was reported that the vns patient was experiencing an increase in seizures.The neurologist planned to give the patient new medication.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description

The nurse at the treating physician¿s office reported that they recently performed vns programming changes, but they have not worked.The vns is felt to not be working.She reported that the magnet did not work the morning of (b)(6) 2014 and resultantly the patient had a seizure.She said that they feel the magnet is not working, and the patient has also been having more seizures since may.The patient went about 6-8 weeks since december with only 4 seizures and now has increased to having seizures every couple of days, to every day and one day she had two seizures.The patient was actually admitted recently to the hospital due to cluster of seizures.They are trying to get her as controlled as possible and have gone through medication changes as well.It is unclear what the cause of the increased seizures is but the medical staff is wondering if the generator is nearing end of service.The relationship of the increased seizures to pre-vns seizure frequency level was unknown by the nurse.Cyberonics labeling indicates that vns magnet therapy is an adjunctive therapy and not all patients benefit from its use.

• 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: 3916647
• MDR Text Key: 4764508
• Report Number: 1644487-2014-01706
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Model Number: 103
• Device Lot Number: 3065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2011
• 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): Required Intervention
• Patient Age: 34 YR