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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 01/01/2012
Event Type  Injury  
Event Description

Good faith attempts for additional information have been unsuccessful to date.

 
Event Description

It was reported that the patient has had ongoing aspiration pneumonia and the physician was not certain if the vns was contributing to the vns initially, but ultimately felt it was not. No known surgical intervention has occurred to date.

 
Manufacturer Narrative

Describe event or problem, corrected data: the supplemental report #3 inadvertently did not report this information.

 
Event Description

Additional information was received that the patient is now going to have explant surgery due to the previously reported issues. However, surgery has not occurred to date. The patient had vocal cord injections in (b)(6) 2012.

 
Manufacturer Narrative

Age at time of event, corrected data: the initial report inadvertently reported the incorrect age at time of the event. Outcomes attributed to adverse event, corrected data: the initial report inadvertently did not check this data. Date of event, corrected data: the initial report inadvertently reported the incorrect date of onset. Describe event or problem, corrected data: the initial report inadvertently did not report the information regarding the injections.

 
Event Description

It was reported by the patient's mother on (b)(6) 2012 that her son is in the hospital had it was confirmed that he had left vocal cord paralysis. The patient's mother reported that the patient has been in and out of the hospital for months now due to the problems with the vocal cords and aspiration pneumonia. She reported that the patient had been in and out of the hospital 10 times over the last year for aspiration pneumonia and the physician's finally today said it is left vocal cord paralysis. She states the neurologist turned patient's generator off on (b)(6) 2012. The patient had an aspiration study done the week prior and the patient's mother indicated that the aspiration was bad. The only thing that has changed is they increased one of his medications recently. No additional information is known at this time.

 
Manufacturer Narrative

 
Event Description

Addition information was received that the physicians felt the aspiration pneumonia and vocal cord paralysis was due to chronic vagal nerve stimulation per the patient's mother. It is unclear if there events are occurring with stimulation cycles. The patient's vns was turned off on (b)(6), and he has been showing some slow improvement since that time. The patient was in a swallow study and was placed on honey-thickened liquids to help with the aspiration pneumonia he has experienced; the next step would be a feeding tube.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2749205
Report Number1644487-2012-02363
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/20/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2009
Device MODEL Number302-20
Device LOT Number1538
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received05/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/19/2006
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: 09/18/2012 Patient Sequence Number: 1
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