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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 304-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Paralysis (1997)
Event Date 12/10/2018
Event Type  Injury  
Event Description
It was reported by the physician that the patient experienced vocal cord paralysis since their vns implant surgery.The patient was referred to an ent.No further relevant information has been received to date.
 
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Brand Name
LEAD MODEL 304
Type of Device
LEAD
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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key8493994
MDR Text Key141300436
Report Number1644487-2019-00676
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750139
UDI-Public05425025750139
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/04/2022
Device Model Number304-20
Device Lot Number204660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received03/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age36 YR
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