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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
Event Date 11/27/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient presented with dilated pupils, tremulous behavior and showed signs of horner's syndrome after vns implant surgery. It was reported by the that the patient's symptoms appeared to be the same when the device output current was programmed off and therefore the patient's generator was programmed on. The physician indicated that the patient's horner's syndrome was related to the vns surgery. It was reported that the patient's symptoms had not resolved post surgery to date. The reported tremulous behavior was reported to be caused by the patient's seizures per the physician. No known surgical intervention has occurred to date. No further relevant information has been 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8296503
Report Number1644487-2019-00189
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number304-20
Device LOT Number204637
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/09/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/19/2018
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: 02/01/2019 Patient Sequence Number: 1
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