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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 04/01/2010
Event Type  Malfunction  
Event Description

It was initially reported by the physician that the pt showed high lead impedance on system mode diagnostics. Pt's device was turned off and pt was referred to the surgeon for a full revision surgery. Additional info received stated that the pt had a full revision surgery. While replacing the lead, the surgeon noticed that one of the electrodes was off the vagus nerve. Surgeon did not visualize any breaks. Pt was implanted with a new lead and diagnostics on the new device showed everything working within normal limits. Good faith attempts to obtain explanted products for analysis has been unsuccessful till date.

 
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 Key1701618
Report Number1644487-2010-01208
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/19/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/19/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number302-20
Device LOT Number200788
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/19/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2008
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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