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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/29/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that this patient was doing fine right after vns surgery, but about a week later complained of hoarseness, shortness of breath and was unable to speak. The ent stated that the patient had left vocal cord paralysis and leukoplakia. The left vc paralysis was stated to most likely be secondary to swelling and inflammation around the nerve after the vns was placed since the symptoms occurred 1 week after surgery. The patient was prescribed antibiotics and steroids due to the symptoms. The doctor stated it might take months for vcp to improve. The patient¿s vns device has not been turned on since surgery. It was also stated that this patient is a heavy smoker. The patient did also complain of numbness on the left neck at the neck incision. Additional information was received from the surgeon indicating that the patient's shortness of breath is likely due to left laryngeal weakness, and that the heavy smoking at approximately 1. 5 packs per day contributes to this as well. The vocal changes are due to laryngeal weakness, and the leukoplakia of the larynx is due to smoking. The patient's numbness at the incision site is an anticipated result of a neck incision. No other relevant information has been received to date.

 
Manufacturer Narrative

Event description, corrected data: the initial report inadvertently did not state the patient's sore throat and increased mucus production. Patient problem codes, corrected data: the initial report inadvertently did not include pain and discharge as patient problem codes.

 
Event Description

It was reported that this patient presented with a sore throat and increased mucus production when visiting the ent regarding their vocal cord paralysis and leukoplakia.

 
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Brand NameLEAD MODEL 304
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 Key7230517
Report Number1644487-2018-00126
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/31/2018
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 Number204097
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/24/2017
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: 01/31/2018 Patient Sequence Number: 1
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