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

Model Number 302-20

Device Problems Fluid/Blood Leak (1250); Fracture (1260); High impedance (1291)

Patient Problems Cognitive Changes (2551); No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2016

Event Type  malfunction  

Event Description

It was reported that the patient¿s generator registered high lead impedance shortly after generator replacement surgery on (b)(6) 2016.The generator was reported to have been pulse enabled leading up to the high impedance reading.During the appointment, the patient looked to the left, and the impedance moved from approximately 10,000 ohms to the 6000s ohms range.Lead impedance was reportedly within normal limits at the conclusion of the replacement surgery.X-ray images were received and reviewed by the manufacturer.The generator was placed normally per labeling.Due to the angle of the generator and quality of the image, the insertion of the lead pin could not be fully assessed.The feedthru wires appeared to be intact.The lead electrodes appeared to be appropriately placed per labeling.There were no apparent sharp angles or gross fractures of the lead that could be seen in the portions of the lead that could be visualized.The lead appeared obscured by the generator based on the lead tract.However, it is uncertain if the lead is actually behind the generator.Based on the x-rays received, the cause for the high impedance could not be determined.There was no visual indication of damage to the generator or lead.Nonetheless, the presence of a micro-fracture in the lead could not be ruled out.Surgery to address the high impedance has not occurred to date.No additional pertinent information has been received to date.

Event Description

It was reported that a high impedance flag continued to be observed on the patient¿s vns system.Multiple body positions were attempted with the same result.The patient¿s caregivers reportedly noted that they believed "something was wrong with [their] child's battery" in the summer of 2016 due to increased behaviors at school and home.The generator that was explanted in the previous generator replacement case underwent product analysis.When received, the internal data was downloaded from the pulse generator.Review of the data indicated that the generator had reached an end of service condition.Additionally, there was evidence of increased impedance during the use life of the generator.The suspect lead and paired generator were explanted.The explanted lead and generator were received by the manufacturer and are undergoing product analysis.

Event Description

Product analysis was completed on the other returned generator.Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device.The device output signal was monitored for more than 24-hrs in a simulated body temperature environment.The pulse generator showed expected level of output currents and no signs of variation.Both interrogation and system diagnostic tests were performed.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery measured 2.984 volts during functional testing and showed an ifi=no condition.The internal device data showed that 3.159% of the battery had been consumed.The internal device data contained evidence of increased impedance during the implant life of the device.One day following the implant of the device, the generator registered a change of impedance from 5659 ohms to 13572.The extended impedance history also contained evidence of high impedance as early as the date of implant.There were no performance or any other type of adverse conditions found with the pulse generator.Product analysis was completed on the returned lead portions.Note that since a portion of the lead was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the connector pin existed at least once.Inspection of the first portion of the returned lead showed the outer silicone tubing has an abraded opening approximately 9.4-10cm from the boot.Inspection of the second portion of the returned lead showed the outer silicone tubing is abraded open at approximately 21-21.3cm from the boot.The lead assembly has dried remnants of what appear to have once been body fluids inside the outer silicone tubing due to the abraded outer tube openings.Impedance measurements to identify potential discontinuities were performed, and showed no discontinuities within the returned lead portions.Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portions.

• 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: 6181472
• MDR Text Key: 62959835
• Report Number: 1644487-2016-02894
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2005
• Device Model Number: 302-20
• Device Lot Number: 8773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/03/2017; 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2003
• 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 Outcome(s): Required Intervention
• Patient Age: 19 YR