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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/18/2011
Event Type  Injury  
Manufacturer Narrative

 
Event Description

A patient reported to a company representative that she had a sonogram in order to check for a stroke and it was observed that the vns lead wire had punctured her jugular vein at the time of implant and the sonogram could see blood clots present at the site of the reported puncture. Review of the manufacturing records for the lead revealed no anomalies during manufacture of the device. No additional relevant information has been received to-date.

 
Event Description

Follow-up from the surgeon who implanted the device revealed there was no issue related to vns regarding the jugular vein at the time of surgery or after a one-week post-operative check-up. The surgeon stated the vns lead wire did not puncture the jugular vein and cause blood clots afterward. The surgeon stated he has not seen the patient in 5 years.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5447165
Report Number1644487-2016-00359
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 01/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/03/2014
Device MODEL Number303-20
Device LOT Number2837
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/19/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/12/2010
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: 02/19/2016 Patient Sequence Number: 1
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