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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102

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CYBERONICS INC PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 07/01/2011
Event Type  Injury  
Event Description

It was reported that approximately a month ago, the physician attempted to wean the patient off her depakote and she began having increased seizures. They increased her vimpat, and according to the patient, her settings "are the highest they can go". The physician ordered a brain mri and reportedly, the technician told her that it showed "right temporal lobe swelling". The patient has been referred to another physician for further evaluation. Attempts for further information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2263378
Report Number1644487-2011-02228
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/22/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date06/30/2012
Device MODEL Number102
Device LOT Number2734
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/22/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2010
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/21/2011 Patient Sequence Number: 1
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