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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 03/01/2010
Event Type  Injury  
Event Description

It was initially reported that the patient was recently turned on a few prior and was now experiencing some swelling in her neck and throat, and has been unable to turn her head. It was said that the patient was diagnosed by her treating neurologist that she has a neuroma. The patient was said to have been given a steroid injection, which provided some improvement. It was also indicated that the patient is experiencing some painful stimulation in the neck. No further details have made available on the events. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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Brand NameLEAD MODEL 304
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1698103
Report Number1644487-2010-01109
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/22/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2013
Device MODEL Number304-20
Device LOT Number201288
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/22/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2009
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: 05/21/2010 Patient Sequence Number: 1
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