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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
Device Problems Fracture; High impedance
Event Date 01/01/2008
Event Type  Malfunction  
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

It was initially reported that the vns pt had their lead and generator replaced due to an unk reason. Further follow up with the surgeon revealed that the pt had the lead replaced due to a lead fracture that was visualized on x-rays, and the generator was replaced at that time as well. Further follow up with the referring neurologist revealed that the pt was a new pt to the physician and when the device was initially interrogated and tested, high lead impedance resulted. The physician disabled the device at that time, and referred the pt for x-rays and to the surgeon to replace the device. The radiologists x-ray assessment indicated that there was "a disconnect of the electrodes in the neck". There was no report of manipulation of the device or trauma. The explanted lead and generator were discarded following surgery, and the devices are therefore not available to be returned to manufacturer for analysis.

 
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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 Key1467996
Report Number1644487-2009-01141
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/08/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/03/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2006
Device MODEL Number302-20
Device LOT Number010489
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/08/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2004
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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