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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 06/27/2008
Event Type  Malfunction  
Event Description

Reporter indicated vns was opened, but was not utilized because it was defective. F/u with the surgeon revealed the lead was placed in the pt's vagus nerve, but the electrode keep falling off of the nerve. A second lead was used and everything worked well. The handheld has been returned to the mfr and is pending product analysis.

 
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Brand NameLEAD MODEL 303
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1081542
Report Number1644487-2008-01722
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 06/27/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2009
Device MODEL Number303-20
Device LOT Number1686
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/14/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/27/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/29/2006
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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