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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 12/05/2013
Event Type  Injury  
Event Description

It was reported that the patient has been diagnosed with left vocal cord paralysis by an ent after full vns system replacement. Both the lead and generator were replaced. It was reported that the patient will be referred to speech re-training. It was reported that the patient has benefitted from vns therapy. It was reported that the patient experienced dysphonia upon return from surgery. The dysphonia was initially attributed to disorders resulting from intubation (laryngitis post intubation), but with continuing unrest, despite correct treatment, the situation has been reevaluated and paralysis of the recurrent laryngeal nerve was confirmed. It was reported that the device was not programmed on until (b)(6) 2013 which was after the dysphonia problems. No additional information has been received to date.

 
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Brand NameLEAD MODEL 302
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 Key3546950
Report Number1644487-2014-00006
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/05/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2017
Device MODEL Number302-20
Device LOT Number3604
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/05/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/23/2013
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: 01/02/2014 Patient Sequence Number: 1
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