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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 04/26/2010
Event Type  Malfunction  
Event Description

A vns programming physician reported to our consultant that they had a vns patient and after performing a normal mode and system diagnostic test the results indicated: high: limit: dcdc: 7, eos: no. It was additionally reported that the patient has been experiencing pain with stimulation in the neck region that started about 2-3 weeks ago. The pain became worse the last couple of days. The patient had used his magnet and disabled his device and pain went away. No trauma or manipulation to the device was reported. The patient's vns was programmed off. The patient's depression has been increasing since their vns has been programmed off. X-rays were received for review by manufacturer and their generator placement appeared normal and the filter feed-throughs appeared to be intact. The lead connector pin was verified to be fully inserted into the generator connector block. The lead was verified to be intact at the connector pin. Strain relief could not be assessed due to x-ray reviews provided, as views of the neck region were not sent for review. No acute angles or obvious gross lead discontinuities were observed in the visible portion of the lead. A portion of the lead, located behind the generator, could not be assessed. The patient is pending insurance approval to be scheduled for full revision surgery. No surgery date is set at this time.

 
Manufacturer Narrative

Method: manufacturer reviewed x-rays of implanted device. Results: x-ray reviewed by manufacturer, no gross lead discontinuities visualized. Conclusions: device malfunction 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 Key1711609
Report Number1644487-2010-01254
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/26/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/26/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number302-20
Device LOT Number1158
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/26/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2005
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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