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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 07/11/2011
Event Type  Injury  
Event Description

It was reported by a neurologist that a vns patient experienced coughing, hoarseness, and difficulty swallowing after his vns settings were increased from. 75 ma to 1 ma. The treating physician indicated the patient then experienced vocal cord paralysis and the patient has not recovered. Moreover, the neurologist indicated that when the patient had vns explanted due to high impedance (mfr report # 1644487-2011-01816), the surgeon saw that the superior electrode had been pulled partially from the nerve and the tissue was scarred. The patient's mother indicated the patient did not have a physical injury that could have contributed to the event. At the moment, good faith attempts to obtain further information regarding the event have been unsuccessful to date.

 
Manufacturer Narrative

Correction: patient identifier was inadvertently reported incorrectly on the initial medwatch and has been corrected. (b)(4).

 
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Brand NameLEAD MODEL 302
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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2372099
Report Number1644487-2011-03066
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number302-20
Device LOT Number2777
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received12/19/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2010
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: 12/14/2011 Patient Sequence Number: 1
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