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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/19/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Information was received indicating that the patient's voice was "extremely" hoarse. The hoarseness was not cyclical but constant. The patient was referred to an ent for injects. The hoarseness was present after the patient's implantation surgery in (b)(6) 2016 where the patient's generator was programed on. The patient's generator was disabled in february to allow the patient to heal. Diagnostics of the patient's device were within normal limits. No additional relevant information has been received to date.

 
Event Description

It was later explained by the physician that the patient's voice was hoarse and getting progressively worse, along with coughing and aspiration of both solids and liquids. It was also explained the patient has left vocal cord paresis as opposed to paralysis.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6378738
Report Number1644487-2017-03299
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number303-20
Device LOT Number203926
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/03/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/27/2016
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: 03/04/2017 Patient Sequence Number: 1
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