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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101

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CYBERONICS, INC. PULSE GEN MODEL 101 Back to Search Results
Model Number 101
Event Date 01/01/2004
Event Type  Injury  
Event Description

Pt's predominant seizures were noted as having an increase in the ictal severity of seizures at the 2-year follow-up. The pt was also noted as having tonic-clonic seizures at the most recent visit (3-years post implant) not previously noted for the pt, which appears to be an increase from baseline. A search performed in the mfr's programming history database did not reveal any details on the diagnostics for the device. Good faith attempts to obtain add'l info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2230508
Report Number1644487-2011-01858
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/14/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date05/31/2003
Device MODEL Number101
Device LOT Number4813
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/14/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2001
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: 08/12/2011 Patient Sequence Number: 1
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