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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL UNKNOWN Back to Search Results
Event Date 01/01/2013
Event Type  Injury  
Event Description

On (b)(6) 2013 the physicians (authors of the paper) stated that they solved their patient¿s side effects some months after implant. They said they have no time to give any further information.

 
Event Description

On (b)(4) 2013 an article titled ¿endoscopic laryngeal patterns in vagus nerve stimulation therapy for drug-resistant epilepsy¿ was reviewed. The article stated that the objective was to evaluate laryngeal patterns in a cohort of patients affected by drug-resistant epilepsy after implantation and activation of a vagus nerve stimulation therapy device. There were 14 consecutive patients that underwent a systematic otolaryngologic examination between 6 months and 5 years after implantation and activation of a vagus nerve stimulation therapy device. The article reported that they observed three different laryngeal patterns; four patients showed left vocal cord palsy at the baseline and during vagus nerve stimulation (captured on mfr. Report # 1644487-2013-02125, this report, 1644487-2013-02126, and 1644487-2013-02127), seven showed left vocal cord palsy at the baseline and left vocal cord adduction during vagus nerve stimulation (captured on mfr. Report # 1644487-2013-02128, 1644487-2013-02129, 1644487-2013-02130, 1644487-2013-02131, 1644487-2013-02132, 1644487-2013-02133, and 1644487-2013-02134), and three patients showed a symmetric pattern at the baseline and constant left vocal cord adduction during vagus nerve stimulation (captured on mfr. Report # 1644487-2013-02135, 1644487-2013-02136, and 1644487-2013-02138). The article stated that the vast majority of patients (12/14) reported mild immediate dysphonia after implantation of the vns device, however only 4/14 patients remained dysphonic at the time of their laryngeal examination that occurred between six months and five years after surgery. One patient reported dysphonia at more than one year after surgery. All four patients showed left vocal cord palsy at the time of the examination. It was stated in the article that for the group of patients that showed left vocal cord palsy both at rest and during phonation with the vns both armed and disarmed (4/14 patients), only one of these patients reported dysphonia at the time of examination. It was stated that this laryngeal pattern seems related to iatrogenic damage to the vagus nerve, which is unable to conduct physiological or supraphysiological stimuli. The second group (7/14 patients) that showed left vocal cord palsy at the baseline both at rest and during phonation and persistent left vocal cord adduction during the whole vns stimulation period; only three reported dysphonia persisting at the time of examination, showing good right vocal compensation. The third group of patients (3/14 patients) that showed a symmetrical laryngeal pattern at rest and during phonation at baseline and left vocal cord adduction during the entire vns stimulation period had no patients that reported dysphonia at the time of examination. It was stated that the nerve is not completely damaged in these patients.

 
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Brand NameLEAD MODEL UNKNOWN
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3229051
Report Number1644487-2013-02124
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2013
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 Received07/24/2013
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: 07/16/2013 Patient Sequence Number: 1
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