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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104

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CYBERONICS, INC. PULSE GEN MODEL 104 Back to Search Results
Model Number 104
Event Date 02/01/2011
Event Type  Malfunction  
Event Description

It was reported via clinic notes received dated (b)(6) 2011 that the patient had recently been experiencing a new seizure type described as facial flushing, stiffening, and then shaking of all of her extremities lasting 15 to 30 seconds. Diagnostics of the patient's vns indicate normal device function. It was noted that the patient's parents were pleased with the patient's seizure control. No interventions were taken in response to the change in seizures. Attempts for further information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 104
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key2314934
Report Number1644487-2011-02442
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/13/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/13/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date06/30/2010
Device MODEL Number104
Device LOT Number200859
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/13/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2008
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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