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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 06/23/2010
Event Type  Injury  
Event Description

The pt recently had surgery for routine generator replacement, and during surgery, the surgeon cut the lead in error and therefore had to implant a new lead as well. The surgeon uses a single incision implant technique. The pt was seen by the neurologist for the first follow up appointment since surgery, and when the device was programmed on to "the lowest setting", the pt experienced intolerable coughing and painful stimulation in the neck and was not able to tolerate any stimulation. The surgeon was notified of the events, and it was noted by the surgeon that it is possible that based on these side effects, that the lead may be implanted on the wrong structure, possibly the phrenic nerve, rather than the vagus nerve. The pt is scheduled for surgery to have the lead replaced by a new surgeon, which is scheduled to occur on (b)(6)2010. Per the neurologist, diagnostic testing was performed which revealed normal device function; however, the specific results were not provided. In addition,the neurologist noted the device has been programmed off at this time.

 
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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 Key1801204
Report Number1644487-2010-01830
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/14/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2013
Device MODEL Number302-20
Device LOT Number2482
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/14/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/11/2010 Patient Sequence Number: 1
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