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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 07/26/2016

Event Type  malfunction  

Event Description

It was reported that a patient had high impedance identified by his physician.The physician ran multiple system diagnostic tests that gave high impedance results.The patient had a full replacement on (b)(6) 2016.The lead and generator were both returned to the manufacturer and are both currently undergoing product analysis.After replacement, the impedance values were found to be within normal limits.

Manufacturer Narrative

Supplemental mdr #1 inadvertently did not include information regarding pitting that was identified in the lead analysis.

Event Description

The abraded openings identified in analysis of the lead most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.Pitting and corrosion were identified on the coil surface of the lead.

Event Description

Product analysis on the returned lead portions was completed on 08/29/2016.A portion of one of the inner silicone tubes and quadfilar coils past the electrode bifurcation was not returned for analysis and therefore an evaluation could not be performed on those sections of the lead.The lead was returned in 6 portions.Visual analysis of the lead identified two coil breaks on one portion of the returned quadfilar coil.Scanning electron microscopy was performed on the two coil breaks, with one having extensive pitting which prevented identification of the coil fracture type, and the other broken coil end having evidence of a stress induced fracture with mechanical damage.Visual analysis identified another coil break on another portion of the lead, proximal to the anchor tether.Scanning electron microscopy identified the area as having evidence of a stress induced fracture with mechanical damage and no pitting.The presence of metal pitting suggested that stimulation was present for a certain period of time.Abraded openings were identified on the outer and silicone tubing in multiple locations.A half set screw mark was identified on the connector pin, indicating the lead had not been fully inserted into the generator cavity at one time.An additional set of screw marks were found on the lead connector pin indicating that at one point in time a good mechanical and electrical connection was present.No other anomalies were identified in review of the returned lead.The explanted generator was also returned and had product analysis completed on 09/12/2016.The generator confirmed proper functionality in its ability to measure impedance values as well as in its ability to provide appropriate output current.No abnormalities were identified for the generator.

• 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: 5908690
• MDR Text Key: 54060644
• Report Number: 1644487-2016-01939
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Model Number: 302-20
• Device Lot Number: 2844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2010
• 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: 9 YR