MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problems High impedance (1291); Difficult to Insert (1316)

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

Event Date 11/22/2017

Event Type  malfunction  

Event Description

It was reported that the physician encountered a vns generator that was defective in the operating room.The device was not implanted because a connection did not work like the previous time.A company representative followed up with the facility and found that the defective device was actually a vns lead but no other additional relevant information has been received to date.

Event Description

It was reported that the surgeon failed to implant the vns generator due to the lead problem.

Event Description

It was reported that the surgeon had a problem connecting the lead and there was resistance at the first rim of the connector boot.The surgeon felt that there was too much rubber on the connector boot portion of the lead.A review of previous internal investigations that insertion difficulties could potentially be related to a number of factors.One potential cause is the that the diameter of the large o-ring boot is critical.All leads must meet a force requirement; however, it was found that the diameter of the large o-ring boot can be too high but within specification resulting in the leads requiring more force than the force maximum to fully insert the lead pin into the generator cavity.The device has not been returned to date so dimensional analysis could not be performed.Another potential contributing factor is the manufacturing work instruction allows for deionized water to be used as lubricant during manufacturing tests.It is known that the main manufacturing facility does not use this technique however it speculated that this technique may have been used at a secondary manufacturing facility.Manufacturing records confirmed the lead passed quality control inspection when it was manufactured at the secondary manufacturing facility.Based on the surgeon's report and manufacturing records it appears that the cause of the insertion difficulties could potentially be related to the events studied in the previous investigation.

• Brand Name: LEAD MODEL 303
• 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: 7138168
• MDR Text Key: 95608569
• Report Number: 1644487-2017-05061
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2020
• Device Model Number: 303-20
• Device Lot Number: 300495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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: 28 YR