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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS VNS THERAPY SYSTEM VAGUS NERVE STIMULATOR

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CYBERONICS VNS THERAPY SYSTEM VAGUS NERVE STIMULATOR Back to Search Results
Model Number 102
Event Date 04/01/2009
Event Type  Injury  
Event Description

Pt had cluster of 7 seizures over 2 days, resulting in emergency room visit and hospitalization on epilepsy monitoring unit. A few days prior to this, patient had a suspected seizure that was different in appearance than prior events. Medication changes were made. During the hospitalization, patient was placed on eeg telemetry where two seizures were recorded with a period of asystole lasting 18 seconds during the seizure. The patient did not have a prior history of bradycardia or cardiac difficulties. Since patient had an implanted vagus nerve stimulator, this was interrogated and tested to ensure that the device was working properly. Testing the device was not associated with change in heart rate. Epilepsy team believes that the seizure was associated with asystole and not the vagus nerve stimulator, but since asystole had been reported in a few instances of new implants with vns, the vns device was watched carefully in this patient. A cardiac pacemaker was implanted and the vns was tested during this procedure. The vns was not found to interfere or affect the cardiac pacemaker. The vns is gradually being reprogrammed to the patient's usual settings as a treatment for her seizures. Patient's medications were adjusted during the hospitalization, and she was discharged twelve days later in 2009. Pt seen in clinic today for follow-up of vns and no further problems have been noted. Diagnosis or reason for use: intractable epilepsy.

 
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Brand NameVNS THERAPY SYSTEM
Type of DeviceVAGUS NERVE STIMULATOR
Manufacturer (Section D)
CYBERONICS
houston TX
MDR Report Key1365329
Report NumberMW5010799
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/16/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 04/16/2009 Patient Sequence Number: 1
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