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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS BIPOL LEAD MODEL 300

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CYBERONICS BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-30
Event Date 07/27/2005
Event Type  Injury  
Event Description

The patient or patient's representative reported on (b)(6) 2005 that the patient's vns implant lead migrated over the larynx, and the left vocal cords were not working. The patient had generator replacement for re-implant with a smaller device and leads were repositioned at that time. The generator replacement due to migration of the device was previously reported in manufacturer report #: 1644487-2005-00735. The surgeon's notes further reported that the device's lead had gradually migrated medially. Another reason for generator replacement was persistant mild trouble swallowing (dysphagia) that occurred intermittently. The persistent dysphagia was possibly related to the medial migration of the lead. Consult notes from the surgeon dated (b)(6) 2001 reported that at that time, the patient had normal vocal fold mobility. Some reflux was noted. The surgeon documented that it was possibly globus symptoms related to reflux. He was not sure how the vagal nerve stimulation would exacerbate some reflux, but nevertheless he indicated that it could be possible. However, notes dated (b)(6) 2005 reported that "on fiberoptic examination today reveals normal moving cords bilaterally whereas just in couple of months she had no movement of the left vocal fold. There may have just been a temporary neurapraxia from the stimulator. " a study nurse reported that the patient had began exercising and losing weight and the lead migration and dysphagia occurred as a progression of the patient's improved physical conditioning. The generator replacement and lead repositioning was considered by the surgeon to also be cosmetic. Follow up with the patient's currently treating vns physician in (b)(6) 2014 revealed that he is not aware of the patient ever having vocal cord paralysis. He has never noticed any symptoms from the patient that would suggest vocal cord paralysis. He reports that he does vaguely recall where she has talked about that she does talk lower and slower with the physician. However, she does not have voice alteration.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS
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 Key3774139
Report Number1644487-2014-01114
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/28/2005
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2000
Device MODEL Number300-30
Device LOT Number16551C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/28/2005
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/03/1998
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: 04/25/2014 Patient Sequence Number: 1
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