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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Neck Pain (2433); No Code Available (3191)

Event Date 12/11/2016

Event Type  malfunction  

Event Description

It was reported by a physician that a vns patient was in referral for full revision.Clinic notes from a visit on (b)(6) 2017 provided that high lead impedance was discovered on diagnostics at that visit.The notes also stated that the patient has had a cough and neck pain for a long time.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Full revision surgery occurred (b)(6) 2017.The explanted generator was received for analysis, which is underway, but has not been completed to-date.The explanted lead has not been received by the manufacturer to-date.

Event Description

Analysis of the generator was completed.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Proper functionality of the generator to provide programmed output currents was successfully verified.The septum was not cored, eliminating a potential unintended electrical current path through body fluids.The device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal.The diagnostics were as expected.An automated electrical evaluation showed that the generator performed according to functional specifications.The battery measured, 2.875 volts and shows an ifi=no condition.The downloaded data revealed that 70.169% of the battery had been consumed.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: 6413672
• MDR Text Key: 70305674
• Report Number: 1644487-2017-03412
• 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
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2011
• Device Model Number: 302-20
• Device Lot Number: 2224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2008
• 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: 53 YR