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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 03/29/2010
Event Type  Malfunction  
Event Description

It was initially reported that diagnostics performed indicated that high lead impedance was present, but specifics were not available. It was also mentioned by the parent that the magnet activations were no longer being perceived for approx two months prior. The pt's seizures were also said to be "different", but no further details have been made on the issue. X-rays were taken and sent to the mfr for analysis. No gross lead fractures or discontinuities were visualized on the portions of the lead body that could be assessed. However, the image quality in the neck area was poor, and there was a portion of the lead body located behind the generator that could not be assessed. Based on the x-rays received, there were no gross lead discontinuities or anomalies observed that could be contributing to the high lead impedance event. However, a led discontinuity cannot be ruled out on the portions of the lead that could not be fully assessed. Good faith attempts to obtain additional info have been unsuccessful to date. A review of the mfr's programming history database indicated that the last known diagnostics were within normal limits.

 
Manufacturer Narrative

Device failure is suspected.

 
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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 Key1686255
Report Number1644487-2010-01017
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/29/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/27/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2007
Device MODEL Number302-20
Device LOT Number011863
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/29/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2005
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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