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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 11/03/2010
Event Type  Injury  
Event Description

Reporter indicated that a vns patient had developed a new seizure type and has suffered injury with falling from the seizures. The reporter feels the new seizures are due to the vns being adjusted. Attempts to the treating neurologist for further information are in progress.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1914038
Report Number1644487-2010-02701
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 11/03/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/01/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2011
Device MODEL Number103
Device LOT Number2355
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received11/03/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2009
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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