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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 06/21/2007
Event Type  Injury  
Event Description

It was reported through a clinical study that a vns patient experienced transverse cutaneous nerve of neck neuropathy post-vns implantation, decreased sensitivity over cervical scar post-vns implantation, and voice hoarseness with stimulation. The severity of the transverse cutaneous nerve of neck neuropathy post-vns implantation and decreased sensitivity over cervical scar post-vns implantation events in accordance to the study coordinator/nurse were mild and had a definite relationship to vns implantation. The events of transverse cutaneous nerve of neck neuropathy post-vns implantation and decreased sensitivity over cervical scar post-vns implantation were noted on (b)(6) 2007 and were noted to be ongoing at the end of study. Moreover, the events were described as not serious adverse events and no intervention was taken for the reported events.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2463092
Report Number1644487-2012-00451
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/01/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2009
Device MODEL Number302-20
Device LOT Number200188
Was Device Available For Evaluation? No
Event Location Other
Date Manufacturer Received08/01/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2006
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: 02/21/2012 Patient Sequence Number: 1
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