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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 04/13/2010
Event Type  Malfunction  
Event Description

Reporter indicated a patient's vns electrodes were displaced. The vns was disabled, and the reporter indicated the patient would be sent for a surgical eval. X-ray films were requested, but ct scans were sent to the mfr which were unable to be interpreted. All further attempts to the reporter for add'l info and the plan of care have been unsuccessful to date.

 
Manufacturer Narrative

Conclusions: device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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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 Key1733184
Report Number1644487-2010-01409
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/17/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/14/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2011
Device MODEL Number302-20
Device LOT Number200991
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/17/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/29/2008
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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