MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Neck Pain (2433)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that high impedance (>=10000 ohms.) was observed on vns patient's system.It was reported that the patient had been feeling pain at neck for two weeks.On (b)(6) 2016, the patient's device was programmed at output current 1.5ma, pulse width 500¿sec, frequency 30hz, on time 30sec and off time 5min.It was reported that the generator was turned off that day.It was reported that x-rays will be performed to see a possible lead discontinuity which could probably be due to a fall.A complete surgical revision will be scheduled but no known surgical interventions have been performed to date.Additional information was received indicating that x-rays have not yet been done, because the parents are quite reluctant about that.It was reported by the physician that in theirs records, there is a notification of the electrode wire-protuberance under the patient¿s skin on the neck; this was on (b)(6) 2014.No coincidental trauma and pain were observed; the device was working normally.It was reported that ultrasound investigation was performed that time, and no structural changes were described: the lead did not look interrupted.

Event Description

Further information was received indicating that the patient underwent lead revision surgery on (b)(6) 2016.The lead was replaced due to high impedance.The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits with 1480 ohms.Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution.It was reported that the explanted lead will not be returned to the manufacturer for analysis as it was disposed.Additional information from the physician indicated that the patient is now ok with a new e lead in place.It was reported that the patient never had any fall, blow or any other trauma in the neck region or area of vns generator.The lead protuberance appeared suddenly on (b)(6) 2010, under the skin on the lower part of her neck.When this happened, an ultrasound investigation was performed and no other intervention was taken; the patient was doing well, had no pain and very rare seizures and her mother reported that vns works well (hoarseness of patient voice).Later in (b)(6) 2016, the protuberance disappeared; the physician thinks that it was the moment when the electrode finally slipped completely from the vagal nerve.As it turned out during the revision, this protuberance was a part of electrode (a non-active one, the ground) that slipped from the vagal nerve.X-ray performed before the surgical procedure, indicated that one electrode was not in the correct place.It was reported by the physician that the reason must be an inappropriate position-fixation of electrodes when implanted.

Event Description

Additional information was received from the physician indicating that the day of the implant, on (b)(6) 2014, the device was tested and system diagnostics returned impedance results within normal limits with 1480 ohms.It was reported that on (b)(6) 2014 (after the lead protuberance appeared on (b)(6) 2014), the vns system was still ok and system diagnostics returned impedance results within normal limits with 2194 ohms.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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 Key: 5731782
• MDR Text Key: 48519892
• Report Number: 1644487-2016-01349
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: 302-20
• Device Lot Number: 202126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 10 YR