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

Model Number 302-20

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 12/31/2014

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that patient underwent full vns system revision surgery on (b)(6) 2016 due to lead discontinuity and prophylactic replacement for the generator.The explanted products were received by the manufacturer.Analysis of the devices is underway, but it has not been completed to date.

Event Description

Additional information was received that the high impedance was first noticed on follow up visit on (b)(6) 2015.Patient was complaining of tingling and itching in the chest around the site of the generator.On initial interrogation, the lead impedance was 9666 ohms.Nurse switched off the stimulator and the itching and discomfort in the chest abated very quickly.The explanted lead only was received and analyzed.During analysis, lead fracture was verified.The outer and inner silicone tubing (positive coil) are punctured open most likely by an electro-cautery tool.Though difficult to state conclusively it is believed that this was most likely caused at explant.Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location.However, due to metal dissolution and mechanical distortion (smoothed surfaces) the fracture mechanism cannot be ascertained.Also, one strand of the positive coil shows appearance suggesting that the coil was exposed to some type of electro-cautery tool (most likely at explant).Since the closest electrode to the bifurcation was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Event Description

The explanted generator was analyzed by the manufacturer.Review of the data downloaded from the pulse generator shows a possible indication of increased impedance; the ¿diagvinitialprechange¿ value of 2631 ohms, the ¿diagvinitialpostchange¿ value of 9298 ohms, and the time of change detection (b)(6) 2014 (explant (b)(6) 2016).Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.This was successfully verified during the analysis.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 2.988 volts as measured during completion of test parameter, shows an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 52.641% of the battery had been consumed.Measured battery voltage and consumed capacity parameters are as expected.There were no performance or any other type of adverse conditions found with the pulse 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: 5719983
• MDR Text Key: 48204080
• Report Number: 1644487-2016-01320
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2013
• Device Model Number: 302-20
• Device Lot Number: 2506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 06/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/01/2016; 07/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2009
• 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: 24 YR