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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 11/20/2009
Event Type  Malfunction  
Event Description

It was reported that high lead impedance readings were obtained during generator revision surgery when the new generator was connected to the existing lead. Upon observation of the lead body, the surgeon noted a clean cut in the silicone tubing directly above the generator pocket. The old leads were cut at the midpoint due to excessive scar tissue around the nerve. A new lead was not implanted at that time due to the scar tissue. No x-rays were taken prior to surgery and there were no reports of pt manipulation or trauma that could have caused or contributed to the reported event. A new lead was implanted on the right vagus nerve at a later date and the high lead impedance readings resolved. The explanted lead has been returned to the mfr and device eval is in process.

 
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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 Key1603856
Report Number1644487-2010-00215
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/06/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/03/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2005
Device MODEL Number302-20
Device LOT Number009541
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/08/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/06/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2003
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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