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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 105 GENERATOR

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CYBERONICS PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 02/07/2014
Event Type  Injury  
Event Description

An article titled "autistic spectrum disorder, epilepsy, and vagus nerve stimulation" was received which included a vns patient who initially experienced improved seizure control following vns implant but was not maintained. At the age of 9, it was observed that the patient was having up to 10 episodes per day of deep inhalation, pupil dilation, truncal flexion, and upper extremity rigidity which lasted up to 30 seconds. Eeg monitoring at that time revealed epileptiform activity arising from the frontal lobes bilaterally. The patient was given lamotrigine which decreased the number of seizures to 3-6 per day. The medication was later increased to the maximum dosage and the seizure activity decreased to once every two days. At the age of 10, the patient began experiencing an increase in seizures with episodes occurring daily and lasting up to 30 seconds. Zonegran was added to the patient's medication regimen which augmented seizure control but with significant side effects. The patient was later weaned off zonegran and implanted with a m105 pulse generator. Prior to implant, the patient was having 1-2 seizures daily. The patient's device settings were titrated up after 5 weeks post-implant, and the patient experienced a decrease in seizure severity and duration (seizures lasting 10 seconds of less). Six months following implant surgery, the seizure frequency increased to 6-10 per day. The patient's device settings continued to be titrated up. At 13 months post-implant, the device settings were increased and the patient's seizure activity decreased to 3-4 per day. Follow-up with the patient¿s following physician revealed that the reason for the increase in seizure frequency was unknown. The patient¿s parents believed vns was not effective in controlling the patient¿s seizures.

 
Manufacturer Narrative

Hull mm, madhavan d, zaroff cm. Autistic spectrum disorder, epilepsy, and vagus nerve stimulation. Childs nerv syst. 2015 apr 29.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
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 Key4803280
Report Number1644487-2015-04800
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number105
Device LOT Number202427
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/28/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/28/2015 Patient Sequence Number: 1
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