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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the vns caused the patient's gastroparesis, and their seizures were still not controlled. It was stated that the device didn't work for the patient and was therefore it was turned off. Scar tissue formed in the patient's neck, which was very painful, even to turn their head just a little bit was reported to be torture. Patient reported undergoing surgery to remove device and scar tissue. Patient also reported that there was damage to the vagus nerve. The patient's neurologist who managed the patient's vns did not know about any of the symptoms or issues. No other relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7008994
Report Number1644487-2017-04735
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/22/2006
Device MODEL Number302-20
Device LOT Number011718
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/15/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2004
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: 11/08/2017 Patient Sequence Number: 1
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