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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 03/01/2011
Event Type  Injury  
Event Description

It was reported by a vns pt that she felt dizzy with stimulation. Also, she indicated she had a pain in the back of her head and her vns lead had been implanted over a goiter that she had, so the lead was now protruding. Follow-up was obtained from the pt's physician's office and they stated the pt did not indeed get dizzy with stimulation; however, the pain's relationship to vns was not known. The device had been "checked" and the doctor's notes indicated "proper device function", although no specifics were available. The site stated that the lead was "not protruding per se", but that the doctor could palpate the wires in the pt's neck, and "everything seemed to be located where it should be". The pt was to undergo a ct scan angiogram to investigate the dizziness and pain further, but the doctor did not indicate that this was to preclude a serious injury. No changes were made to the pt's settings preceding the onset of the events, and no changes had been made when the device was checked. However, later info was given to a company rep stating the pt was referred to a surgeon as she had a lead that was protruding due to the goiter. The surgeon's nurse indicated that the pt may be explanted with no replacement. The pt subsequently underwent a replacement surgery where her generator was explanted. It was not decided if the lead would be replaced yet. Furthermore, it was stated that the issue was the pt's tie-down. During the surgery, the surgeon removed one tie-down and replaced the generator as there was "no issue with the lead at this time". Good faith attempts for further info have been unsuccessful to date.

 
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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 Key2063732
Report Number1644487-2011-00780
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 03/15/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2004
Device MODEL Number302-20
Device LOT Number92102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received03/15/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2002
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: 04/14/2011 Patient Sequence Number: 1
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