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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 102 GENERATOR

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CYBERONICS PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that vns patient has a numbing feeling on her left neck, face, head, and leg when the stimulation is on since more than one month. The patient could not talk due to cyanotic lip. The patient has 5 times of seizure where 3 were stopped by magnet. The physician reported that those adverse events are related to the stimulation and there is an increase in seizures (above pre-vns baseline). The patient parameters are currently at: 1. 75ma, 30hz, 250usec, 30sec on and 1. 8min off. Follow up indicated that the patient¿s parameters were changed to 1. 25ma; 250's; 30s on; 5mins off. The patient feels very little numb during stimulation. The patient will come back after 3 months for the next follow up visit. The drugs were not changed. The seizure start area in the brain is still unknown for the physician. It was observed that patient has abnormal signals from eeg results (from the frontal-temple lobe). Further follow up indicated that the vns system works fine. Numb feeling disappeared after the parameters decrease. However; the patient has several general seizures after this parameters change. Cyanotic lips happen only during general seizures without direct relationship with the stimulation, and are contributed by the seizures (physician thinks not related to the vns). It was reported also that the increase of seizures maybe related to vns or drug change (medicaments changed/not taken by patient without physician's permission).

 
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Brand NamePULSE GEN MODEL 102
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 Key6016651
Report Number1644487-2016-02325
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/19/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number102
Device LOT Number203075
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/19/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/06/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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