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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 01/14/2009
Event Type  Injury  
Event Description

It was reported that following lead revision surgery, a vns patient began experiencing neck pain when turning her neck from the left to right and upon tilting her chin back. During the surgery, the lead has been dropped on the floor. The surgeon soaked the lead in betadine and rinsed it off prior to implanting the lead in the patient. The vns device had not been programmed on after the surgery. There was some redness and swelling at the neck incision site which resolved with antibiotics. However, the patient continued to experience neck pain. The surgeon indicated there was no infection at that time. X-rays were sent to the manufacturer for review, and no discontinuities or anomalies were observed. An ultrasound report was received indicating that there was some fluid around the lead and at the generator site. The neurologist believes the ultrasound report suggests that the patient may have an infection. Both the neurologist and surgeon think the pain may be a neuralgia from the surgery, though this has not been confirmed. Both do not think the event is permanent in nature. The patient was treated with another round of antibiotics. Additional information revealed that the patient was evaluated by a different surgeon. Evaluation by that surgeon showed that the patient's pain in her neck has improved and there is currently no infection. Review of the manufacturing records show that the product was sterilized prior to distribution.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
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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 Key1336467
Report Number1644487-2009-00454
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/11/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2011
Device MODEL Number302-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/11/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2008
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: 03/06/2009 Patient Sequence Number: 1
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