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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. VNS THERAPY PULSE STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

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CYBERONICS, INC. VNS THERAPY PULSE STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY Back to Search Results
Model Number 102
Event Date 11/13/2014
Event Type  Malfunction  
Event Description

The patient is a (b6) male with intractable epilepsy. One month ago the patient underwent removal of his vagal nerve simulator due to "pain," "burning," and discomfort. The device did not prevent/reduce seizure activity as intended. This particular generator and lead were implanted approximately three and a half years ago. Of note, the patient underwent vagal nerve stimulator implantation originally eight years ago. Of note, the patient initially underwent implantation of vagal nerve simulator which was removed and replaced three times due over the course of five years due to various reasons including pain, discomfort, infection and migration of device due to weight loss.

 
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Brand NameVNS THERAPY PULSE
Type of DeviceSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Manufacturer (Section D)
CYBERONICS, INC.
cyberonics building
100 cyberonics boulevard
houston TX 77058
MDR Report Key4371813
Report Number4371813
Device Sequence Number1
Product CodeLYJ
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/19/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator INVALID DATA
Device MODEL Number102
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/19/2014
Event Location Hospital
Date Report TO Manufacturer12/30/2014
Is this a Reprocessed and Reused Single-Use Device? No

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