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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEADM MODEL 304

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CYBERONICS - HOUSTON LEADM MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2017
Event Type  Injury  
Event Description

It was reported that the patient has decreased appetite and was diagnosed with right vocal cord paralysis due to vns lead revision surgery. The patient's new device was programmed to the lowest settings following the surgery and diagnostics were reported to be within normal limits. Lead was replaced due to low impedance and this event was reported in mfr. Report # 1644487-2017-04807. The neurologist and ent are closely monitoring patient's progress. The neurologist does believe that vocal cord paralysis may have caused lack of appetite.

 
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Brand NameLEADM MODEL 304
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 Key7280279
Report Number1644487-2018-00236
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number203924
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/25/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/22/2016
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: 02/19/2018 Patient Sequence Number: 1
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