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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 Type  Injury  
Event Description

The patient reported permanent vocal cord paralysis. The patient has not been evaluated for vocal cord paralysis, but did report to her currently treating physician that her vocal cord does work on the left side. The patient does have a medical history of unrelated health issues, such as fibromyalgia and laryngeal cancer.

 
Manufacturer Narrative

Brand name, corrected data: the initial report inadvertently reported the incorrect data. Model #, serial #, lot #, expiration date, corrected data: the initial report inadvertently reported the incorrect data. Device manufacture date, corrected data: the initial report inadvertently reported the incorrect data.

 
Event Description

On (b)(6) 2014, the nurse reported that the patient has vocal cord paralysis, but the patient has not been seen yet. Follow up with the physician found that the patient was supposed to bring in their old clinic notes to their appointment, but the patient was a no-show. No other information was provided.

 
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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 Key3627219
Report Number1644487-2014-00403
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2006
Device MODEL Number302-20
Device LOT Number009946
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/14/2004
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: 02/13/2014 Patient Sequence Number: 1
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