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

Model Number 304-20

Device Problems Disconnection (1171); Low impedance (2285)

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

Event Date 12/21/2015

Event Type  malfunction  

Event Description

Low impedance was reported to be observed on the patient's vns device.The patient was referred for revision surgery due to the observed decrease in impedance.There was no trauma reported that could have caused or contributed to the low impedance and there were no reported adverse events.The patient underwent revision surgery on (b)(6) 2016.During the surgery, the surgeon observed a lead discontinuity near the generator site.Attempts for additional relevant information were unsuccessful to date.

Event Description

Product analysis for the returned generator demonstrated that accurate resistance measurements were obtained in all instance using various electrical loads.A comprehensive automated electrical evaluation showed that the vns generator performed according to functional specifications.The final electrical test showed an ifi = no condition.There were no performance or any other type of adverse conditions found with the vns generator.Product analysis for the returned lead found abraded an opening on the inner silicone tube, in one locations, and abraded openings on the outer silicone tube.The abraded opening on the outer tubing and the cut ends made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have been body fluids found inside the outer tubing.What appeared to be white deposits were observed in various locations.Energy dispersion spectroscopy was performed on the deposits observed on the connector boot and identified the deposit as containing silicon and sodium.With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide the evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed during visual analysis and no discontinuities were identified.Based on these findings in the product analysis lab, there was no evidence to support the low impedance, short circuit, or fractured lead allegations.It should be noted that a portion of the lead assembly, including the electrodes, was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.

Event Description

It was also reported the patient had an increase in seizures, above pre-vns baseline levels, which began after the lead fracture occurred.The increased seizures continued once the new devices were implanted and was reported, and will continue to be investigated, in mfr.Report 1644487-2016-01782.

• 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: 5371786
• MDR Text Key: 36507977
• Report Number: 1644487-2016-00124
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2016
• Device Model Number: 304-20
• Device Lot Number: 202191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2012
• 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: 7 YR