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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK GENERATOR

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CYBERONICS PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 08/01/2010
Event Type  Injury  
Event Description

It was reported by the vns patient that she experiences "coma seizures" that involve her "having continual seizures that will make her go into a coma. " the patient was unable to clarify if this was status epilepticus. These events have lasted from one night to three weeks. She indicated these events began occurring 9 months following vns implant and the last event has not occurred in about a year. This has reportedly only occurred a few times. A physician at a hospital indicated at least one of the events may have been related to the patient missing a dose of xanax. The patient also indicated that she is experiencing continuous pain at the generator site. She stated vns has improved her daily seizure control. Attempts for additional information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL UNK
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2818118
Report Number1644487-2012-02875
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/04/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/04/2012
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

Patient TREATMENT DATA
Date Received: 11/03/2012 Patient Sequence Number: 1
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