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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 302-30
Event Date 05/05/2010
Event Type  Malfunction  
Event Description

Neurology reported that they had a vns pt that could not longer feel stimulation (magnet and normal mode) and had increased seizures, below pre-vns baseline. System diagnostics testing was performed and yielded 7 / limit / high. The pt's vns programming physician wanted to disable the device related to their high lead impedance but pt did not want him to. The pt has been referred to their surgeon for revision surgery. At this time no surgical date has been set as pt is status post cardiac stent placement and on plavix. The pt did not recall having any trauma to the site prior to their high impedance being attained.

 
Manufacturer Narrative

Device malfunction 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 Key1720407
Report Number1644487-2010-01310
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/05/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/02/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date02/28/2009
Device MODEL Number302-30
Device LOT Number200121
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/05/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2006
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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