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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 12/11/2011
Event Type  Injury  
Event Description

It was reported that the patient was admitted to the hospital on (b)(6) 2011 for seizures. Patient's mother states she is having one seizure after another and is sometimes cyanotic during that time. She states she is in the icu and her doctors don't seem to know anything about her vns. It is unknown if the patient is currently seeing a neurologist or who it is, so no further information can be obtained.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2429803
Report Number1644487-2012-00203
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/28/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2007
Device MODEL Number102
Device LOT Number015094
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/28/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2006
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: 01/27/2012 Patient Sequence Number: 1
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