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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK

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CYBERONICS PULSE GEN MODEL UNK Back to Search Results
Event Type  Malfunction  
Event Description

The following article was received for review. Vagal nerve stimulation for refractory epilepsy: the surgical procedure and complications in 100 implantations by a single medical center" by gilad horowitz, moran amit, itzhak fried, miri y. Neufeld, liad sharf, uri kramer, and dan m. Fliss. The article discusses the implantation and outcomes of 100 vns patients. Information reports that a vns patient had a general performance issue, reported as a failure with the device. No specifics provided. Attempts for further information have been made and no further information attained.

 
Manufacturer Narrative

Citation: vagal nerve stimulation for refractory epilepsy: the surgical procedure and complications in 100 implantations by a single medical center. By gilad horowitz, moran amit, itzhak fried, miri y. Neufeld, liad sharf, uri kramer, and dan m. Fliss. Eur arch otorhinolaryngol springer- verlag 2012.

 
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Brand NamePULSE GEN MODEL UNK
Type of DevicePULSE GEN MODEL UNK
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2727639
Report Number1644487-2012-02207
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/06/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/05/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date08/06/2012
Event Location Other
Date Manufacturer Received08/06/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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