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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 01/17/2013
Event Type  Injury  
Event Description

Additional information was received from the patient that she was diagnosed with left vocal cord paralysis by an ent. The patient reported that she is still having a hard time drinking liquids and regular foods. Clinic notes from the ent follow-up dated (b)(6) 2013 note that the patient experiences aspiration symptoms with think liquids and that she is on a thickened liquid diet. The notes also indicated that the patient is currently working with speech. Clinic notes dated (b)(6) 2013 indicated that the patient was improved since her last evaluation and that she was doing better with swallowing; however, that she was still on liquids. It was noted that her voice was stronger and that she would be sent for ent evaluation. Attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

Reporter indicated that she was admitted to the hospital the day after implant surgery for difficulty swallowing. The patient also reported that she was still having difficulty and was using liquid thickener to help. Further follow-up revealed that the patient was doing much better. Physician indicated that the patient has a "thick neck" and there was a lot of manipulation which caused swelling which caused the patient's swallowing issues. The physician indicated that the patient was doing much better.

 
Manufacturer Narrative

 
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Brand NameLEAD MODEL 304
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 Key2962368
Report Number1644487-2013-00392
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 01/22/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2016
Device MODEL Number304-20
Device LOT Number202265
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/11/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/10/2012
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: 02/14/2013 Patient Sequence Number: 1
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