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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 302-20
Event Date 01/29/2009
Event Type  Injury  
Event Description

It was reported that the vns pt experienced swelling, wound dehiscence and allergic reaction at the electrode site. The pt was reportedly hospitalized and the events were resolved surgically. Diagnostics tests revealed proper device function. It was indicated that there was no pt manipulation that led to the events. It was also indicated that the pt did not have a medical history of allergies prior to vns. The events were determined to be due to wound dehiscence and definitely related to implantation.

 
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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 Key1356631
Report Number1644487-2009-00669
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/04/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2011
Device MODEL Number302-20
Device LOT Number200841
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/04/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2008
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: 04/03/2009 Patient Sequence Number: 1
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