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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 10/09/2009
Event Type  Injury  
Event Description

Reporter indicated a vns pt was experiencing painful stimulation in the neck. The vns was disabled as an intervention. The pt was in an accident in 2009 and has experienced the painful stimulation since that time. X-rays were reviewed by the mfr which did not visualize any anomalies, however; no views of the electrode area in the neck were provided. Attempts for additional info have been unsuccessful to date.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. Review of x-rays by mfr did not reveal any anomalies.

 
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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 Key1549472
Report Number1644487-2009-02678
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/05/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/01/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2010
Device MODEL Number302-20
Device LOT Number200444
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/05/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2007
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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