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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 12/17/2010
Event Type  Injury  
Event Description

Reporter indicated a newly-implanted vns pt was hospitalized for a jugular inclusion. No complications occurred during the surgical procedure itself. Vns diagnostics with the newly implanted vns system were within normal limits. Per the reporter, the pt was taking valproic acid and depakote medications prior to the surgery. Depakote medication is nonspecific cox2 inhibitor (similar to aspirin) and causes oozing during neurosurgical procedures. It is a known practice to give a small dose of desmopressin medication to pts on valproic acid and depakote prior to surgery. Desmopressin medication is believed to cause a release of von willebrand factor, thereby transiently correcting platelet aggregation defects. It is believed the jugular inclusion was caused by blood hypercoagulation from the medication given preoperatively. The pt was placed on heparin medication and the pt was reported as stable. Attempts for further information are in progress.

 
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Brand NameLEAD MODEL 304
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1963310
Report Number1644487-2011-00064
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/19/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/13/2014
Device MODEL Number304-20
Device LOT Number201593
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/19/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2010
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: 01/14/2011 Patient Sequence Number: 1
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