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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 09/01/2014
Event Type  Injury  
Event Description

It was reported that the recently implanted vns patient had been experiencing an increase in seizures and a new seizure type for the past week. On (b)(6) 2014, the patient had a seizure that lasted for approximately 35 minutes and was taken to the er. The patient was given medication and admitted to the icu. The patient¿s seizures were determined to be non-epileptic but a new type for the patient. It was noted that vns had improved the patient¿s epileptic seizures. Follow-up revealed that the patient¿s device was tested and diagnostic results showed normal device function. The patient¿s device pulse width was decreased from 500usec to 250usec. The physician believed that the patient would have an anxiety attack that could trigger seizures if the patient felt stimulation from the device. With the adjustment to the device pulse width, the patient no longer felt stimulation and did not have another event since the adjustment. The patient¿s seizures have improved past pre-vns baseline levels.

 
Event Description

On 03/18/2015 it was reported that the patient¿s device was turned off on (b)(6) 2015. He was having ¿panic attacks¿ that would lead to seizures. The physician believes that the panic attacks may be brought on from the stimulation.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 Key4131946
Report Number1644487-2014-02527
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/08/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2015
Device MODEL Number102
Device LOT Number3747
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/18/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/12/2013
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: 10/01/2014 Patient Sequence Number: 1
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