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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 08/01/2008
Event Type  Malfunction  
Event Description

It was reported that patient's last diagnostics test showed a high lead impedance. It was also indicated that the patient stopped feeling stimulation about three months ago and a mild intensification of seizures occurred. X-rays were reviewed by the physician and he indicated that one electrode (distal to head) is partially uncoiled and displaced. The line containing electrodes does not lie parallel to the normal location of vagus nerve. The patient's device is programmed off and electrode replacement is planned in case of further worsening of epilepsy. Follow up with nurse stated that no trauma occured and x-rays have been sent to manufacturer for further review. No additional information is available.

 
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 Key1350383
Report Number1644487-2008-03105
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/27/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/23/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number302/20
Device Catalogue Number10683
Device LOT Number11/26/2005
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/27/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2003
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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