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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 03/19/2009
Event Type  Injury  
Event Description

Attempts for additional information have been unsuccessful to date.

 
Event Description

It was reported in clinic notes received on 12/16/2011, that the patient experienced an increase in seizures and a change in seizure type on (b)(6) 2009. It was indicated that the patient had developed staring seizures, right hand tremors, and seemed pale and dazed for up to 30-40 seconds. The notes also stated that the patient had an increase in myoclonic partial seizures. The patient's vns settings were adjusted at that appointment. At the patient's next appointment on (b)(6) 2009, it was indicated that the patient was doing much better. It was also indicated on (b)(6) 2009 that the patient was having mood changes and an increase in seizures. Attempts for additional information are underway.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key2414978
Report Number1644487-2012-00115
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2007
Device MODEL Number102
Device LOT Number013177
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/27/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/28/2005
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: 01/13/2012 Patient Sequence Number: 1
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