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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
Event Date 07/10/2015
Event Type  Injury  
Event Description

It was reported on (b)(6) 2015 from the patient that after his vns implantation surgery on (b)(6) 2015 he ended up with a blood clot on his neck at the surgical site. He was on blood thinners after surgery so they stopped those and he started back on warfarin. Follow-up with the neurologist showed that the patient does have a medical history of pulmonary embolism events. No interventions have been taken for the blood clot but the issue is not yet completely resolved.

 
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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 Key5024811
Report Number1644487-2015-05594
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2018
Device MODEL Number304-20
Device LOT Number202878
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/27/2014
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: 08/24/2015 Patient Sequence Number: 1
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