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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 06/27/2009
Event Type  Injury  
Event Description

The patient's treating physician reported that their patient was having increased seizures and that they were a new seizure type since raising their vns settings. When the patient's vns settings were raised from 0. 5ma output current to 0. 75ma output current the event started. The patent's therapy was lowered back down to 0. 25 ma output current and they have now been seizure free for three weeks, the patient since the change in programmed settings has been doing very well with their vns therapy and the treating physician attributes the event to their settings being raised to fast and over stimulating the patient.

 
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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 Key1464534
Report Number1644487-2009-01883
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/05/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number103
Device LOT Number200882
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/05/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2008
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: 09/03/2009 Patient Sequence Number: 1
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