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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

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CYBERONICS INC BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 06/01/2011
Event Type  Malfunction  
Event Description

It was reported that the vns pt would be having his vns lead and generator replaced due to high impedance. Clinic notes were received indicating that the pt has been experiencing an increase in seizures and experiencing a new seizure type involving "cessation of activity and upward eye deviation. " attempts for further information have been unsuccessful to date. Surgery to replace the pt's generator is likely.

 
Manufacturer Narrative

Device failure suspected.

 
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Brand NameBIPOL LEAD MODEL 300
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2325383
Report Number1644487-2011-02427
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/12/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/12/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2003
Device MODEL Number300-20
Device LOT Number01934
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/12/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2001
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: 10/12/2011 Patient Sequence Number: 1
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