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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 04/22/2009
Event Type  Injury  
Event Description

It was reported by the physician that the patient had a drop attack seizure a few days after the generator replacement due to eos. The patient's settings were programmed to the last known settings upon completion of surgery. The physician indicated that he feels that the patient's seizure was attributed to the vns therapy and being turned on abruptly to the last known settings since she had never experienced a drop attack seizure before. The device has been disabled at this time. Diagnostics performed indicate that it is within normal limits. There is no suspected device failure at this time.

 
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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 Key1393199
Report Number1644487-2009-01030
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/22/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2010
Device MODEL Number104
Device LOT Number200981
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/22/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2008
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: 05/21/2009 Patient Sequence Number: 1
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