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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL UNK Back to Search Results
Event Date 06/03/2011
Event Type  Injury  
Event Description

It was reported that the vns patient has been experiencing "vocal cord issues" since implant. The patient was seen by an ent physician who indicated that he believes the lead was implanted too close to the vocal cords. It was also noted that the patient has not seen much efficacy since implant. The patient was reportedly going to see the implanting surgeon for further evaluation however the surgeon's office indicated that the patient has not been seen or made an appointment. Attempts for further information from the neurologist's office have been unsuccessful to date. Attempts for the product information were unsuccessful.

 
Event Description

Additional information was received indicating the patient's vocal cord issue has resolved.

 
Event Description

On (b)(6) 2012, additional information was received indicated that the patient had hoarseness and awakening at night with vns stimulation noted in (b)(6) 2011. It was confirmed that vocal cord issues were related to electrodes being placed too close to the larynx. No hoarseness was noted (b)(6) 2011. On (b)(6) 2011, the hoarseness was intermittent but then constant on in (b)(6) 2011. A note indicated the hoarseness appeared to have resolved following the thyroidectomy. The thyroid issues were not believed to be related to vns.

 
Manufacturer Narrative

 
Manufacturer Narrative

Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".

 
Manufacturer Narrative

Event date, corrected data: previously submitted mdr indicated an incorrect event date. The patient's physician believes that the vocal cord issues are related to the electrodes being placed too close to the larynx at the time of implant; therefore, the event date is the date of implant: (b)(6) 2011. This report is being submitted to correct this data.

 
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Brand NameLEAD MODEL UNK
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2603575
Report Number1644487-2012-01444
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/08/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/19/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/07/2012 Patient Sequence Number: 1
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