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

Model Number 304-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2017

Event Type  malfunction  

Event Description

A call was received from a physician indicating that high impedance was seen with the patient's device.The patient's device was then programmed off.There was no reported trauma or manipulation that is believed to have caused the high impedance.No x-rays were taken at this time and no surgical intervention has occurred to date.A decoder revealed that no high impedance had been seen as of (b)(6) 2016.No other relevant information has been received to date.

Event Description

It was reported that the patient was underwent lead and generator replacement surgery.The surgeon found that the lead appeared intact and the old electrodes appeared to be in full contact with the nerve however it was the surgeon's opinion that the strain relief of the previous lead was not adequate.However the placement of the previous lead has not been evaluated by the manufacturer therefore its unclear if the strain relief was placed per labeling.The surgeon also noted that there was fibrosis adhering the lead electrodes to the vagus nerve and the jugular vein.The surgeon did not want to disturb the scar tissue so the lead was clipped at the electrodes and the new electrodes were implanted above the old electrodes.The explanted lead and generator have not been received to date.

Manufacturer Narrative

"the explanted lead and generator were received." this information was inadvertently left off on mfg.Report #1.Corrected data: device available for evaluation; this information was inadvertently left off on mfg.Report #2.Corrected data.Device evaluated by mfr; this information was inadvertently left off on mfg.Report #1.Corrected data: (b)(4).

Event Description

The explanted lead and generator were received.Analysis was completed for the generator and found that the device met functional specification.During test various electrical loads were attached to the generator and the results of subsequent diagnostic tests were as expected.

Event Description

Analysis was completed on the lead.It was noted that the lead was received in one portion however the segment containing the electrodes and tie downs was not returned.Setscrew marks were observed on the lead¿s connector pin; indicating that there was proper contact between the lead and generator at one point in time.Fractures were identified in the quadfilar coil in two parts of the lead.Scanning electron microscopy was used to evaluate the lead fracture and observed signs of pitting which indicates that stimulation was being provided after the fracture occurred.Abrading openings were also identified in the outer tubing and bodily fluid was found inside the outer tubing in various locations.

• Brand Name: LEAD MODEL 304
• 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: 6358538
• MDR Text Key: 68362159
• Report Number: 1644487-2017-03240
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2015
• Device Model Number: 304-20
• Device Lot Number: 201736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2011
• 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