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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 01/16/2019
Event Type  Injury  
Event Description

It was reported from the patient¿s mother that he was having some troubles. The patient had a recent full replacement in january and now patient has had some adverse events. States was seen by pcp who started antibiotics and found inflammation in throat and both ears. Patient had "szs on and off all day", much different than his normal episodes, with actual convulsions and 15 min postictal period where he would sleep. It appears that the issues may be related to the recent surgery and that the seizures may be side effects of the medications provided but no additional information has been received to date for clarification.

 
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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 Key8433681
Report Number1644487-2019-00544
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 03/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number204213
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/21/2017
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: 03/19/2019 Patient Sequence Number: 1
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