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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 01/17/2011
Event Type  Malfunction  
Event Description

It was reported by a vns pt that she experienced sharp pain in her neck when turning her head along with headaches with pain over her right eye. Add'l info was received from a company rep indicating the pt's treating neurologist had in his notes from (b)(6) 2010 that high impedance was noted. Follow-up was made with the pt treating neurologist and nurse. The nurse indicated that the pt was taken to an mri and results were normal for the pain and headaches, hence she did not know what caused the pain and headaches. No x-rays were taken for the reported high lead impedance and it was unk if pt manipulation or trauma contributed to the reported high lead impedance. Current plans were to increase the pt's vimpat and follow-up in 3 months as the pt's battery is dead. Review of the manufacturer's programming history database was not indicative of high lead impedance although history was limited to (b)(4) 2005.

 
Manufacturer Narrative

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 Key2036841
Report Number1644487-2011-00276
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/17/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/16/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2008
Device MODEL Number302-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/17/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2005
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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