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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304-20

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CYBERONICS, INC. LEAD MODEL 304-20 Back to Search Results
Model Number 304-20
Event Date 12/18/2014
Event Type  Injury  
Event Description

On (b)(6) 2016 an email was received that the patient developed a cellulitis that needs to be removed. Additional information was received that the patient had her battery and lead wires removed on (b)(6) 2016 due to an infection. Patient is not sure if the coils are still intact on the vagus nerve as one of the coils came through the small open wound on patient's neck incision that never healed after she was implanted on (b)(6) 2014. Patient could not remember the month or year this happened. The opening was big enough to insert tip of qtip. Patient stated that the open wound happened approximately about a month after sutures were removed by the surgeon. Patient was instructed to use neosporin on the open wound, keep it dry and let air get to it. No oral antibiotics were given. Patient did not go to primary care provider at this time either. When one of the tie-downs was pushed through the wound opening in patient's neck, patient consulted the surgeon, who discussed that it was patient's body rejecting the device and that patient should be ok since there were two other tie downs in place. In 2015, patient had a mammogram. Patient thinks that the compression from the mammogram machine pulled the wires and made the generator move. Patient had to have surgery on the leads after that because the leads were displaced. Patient underwent repositioning surgery on (b)(6) 2015 for patient comfort. After the leads were repositioned and tied down, patient stated she was ok but still had the small wound on her neck and that it would open and close up on its own and at times leak some fluid. Patient was referred to wound care center for treatment for a couple of months. Patient later got a very bad sore throat, ear ache and was coughing up mucus in (b)(6) 2016. A throat culture was performed but no antibiotics were given. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Additional relevant information has not been received to date.

Event Description

Additional information was received from the neurologist that the patient required a revision of her vns in (b)(6) 2015 secondary to a possible allergic reaction to silicone sheathing. She subsequently had slow wound healing. Patient was seen on (b)(6) 2015 after apparently expressing a ruptured suture. It was not felt by the neurosurgeons to be infected at that time. Patient likely developed a uri in (b)(6) 2016 and then developed a left breast cellulitis necessitating removal of the device.

Event Description

Additional information was received that the patient completed her iv antibiotics on (b)(6) 2016 & her picc line was removed. Patient was told that vns could not be re-implanted as she has too much scar tissues. Due to patient's severe allergic reaction to the device & her body rejecting it, the surgeon will not be implant vns again for patient.

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Brand NameLEAD MODEL 304-20
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key5867152
Report Number1644487-2016-01797
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2017
Device MODEL Number304-20
Device LOT Number3745
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/09/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/18/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 08/10/2016 Patient Sequence Number: 1