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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 10/03/2011
Event Type  Injury  
Event Description

Additional information was received on (b)(6) 2013 when it was reported that the paralysis was first observed soon after implant surgery on (b)(6) 2011. The physician believes the event is due to the vns surgery. The paralysis does not occur with stimulation. It was unknown if the patient had been evaluated by an ent. The patient does not have a medical history of this event prior to vns. The physician reported that the coughing and voice alteration were also soon noticed after the vns implant surgery on (b)(6) 2011. The physician believes they related to both stimulation and surgery. According to the physician, the coughing and voice alteration are associated with stimulation.

 
Event Description

On (b)(6) 2013 it was reported that the vns patient was experiencing a cough and hoarseness that was found on (b)(6) 2011. It was reported that the patient started feeling it soon after vns implant because of laryngeal recurrent nerve paralysis. It was stated that this was resolved on (b)(6) 2011. No further information was provided. Additional information has been requested from the physician but no further 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 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 Key3028936
Report Number1644487-2013-00876
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2014
Device MODEL Number302-20
Device LOT Number201579
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/23/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/22/2010
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: 04/01/2013 Patient Sequence Number: 1
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