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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problems Extrusion; Human-Device Interface Problem
Event Date 06/01/2013
Event Type  Injury  
Event Description

Further investigation revealed that the patient's generator and lead were explanted on (b)(6) 2013.

 
Event Description

It was reported on 06/22/2015 that this patient, who had his device explanted in 2013, went to the er and the xray showed a "square piece of metal" under the skin. The patient was under the impression that the entire device was explanted. It is unknown at this time of the piece of metal found was left over from the vns explant surgery or is unrelated. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was reported that the patient cut himself of the neck area (near the electrodes) while shaving a few weeks prior and that he has now developed an infection at the site. It was reported that the patient has a thin frame and that the electrodes are visible through the wound. It was reported that the wound was full of pus and was "looking bad". The surgeon prescribed antibiotics and has scheduled the patient for explant. The surgery was scheduled; however, no information has been received that the explant has occurred as scheduled.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

Patient will undergo exploratory surgery on (b)(6) 2015 to try to remove the object that is in his neck. The surgeon plans to remove the object and will not remove it if it is affecting a vein. No additional information has been received after the exploratory surgery.

 
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Brand NameLEAD MODEL 304
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 Key3282396
Report Number1644487-2013-02385
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/18/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2016
Device MODEL Number304-20
Device LOT Number202000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/07/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/21/2012
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: 08/12/2013 Patient Sequence Number: 1
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