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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-30
Event Date 07/28/2009
Event Type  Malfunction  
Event Description

It was reported that a patient experienced pain and would grab the electrode and generator site every time the device activated stimulation. Further information was received from the medical professional stating that the patient's dc dc code dropped from 2 to 0 on system diagnostics. Additionally, the patient experienced an increase in seizures below pre-vns baseline which have not resolved by an increase in settings like they have done in the past. Based on clinical symptoms and the diagnostic history of the patient's device, the issue is possibly related to a short-circuit condition.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1491972
Report Number1644487-2009-01764
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/12/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2004
Device MODEL Number302-30
Device LOT Number6822
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/12/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2002
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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