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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/26/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Clinic notes from a surgeon's office were received stating that the patient had lost his voice after lead revision surgery. It was stated that the patient was doing well, except had hoarseness which began after the patient returned home from the procedure. It was reported that the patient saw his ent who was able to do a vocal cord check that found the cords to be dysfunctional. The surgeon stated that at this time, he would allow time for the inflammation to improve and then would be able to better determine recovery after some time. No further relevant information was received to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7922050
Report Number1644487-2018-01733
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 10/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number304-30
Device LOT Number204506
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/07/2018
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: 10/01/2018 Patient Sequence Number: 1
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