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

Model Number 303-20

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Low impedance (2285)

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

Event Date 08/24/2017

Event Type  malfunction  

Event Description

Report received that low impedance was found on a patient's lead.Low impedance was initially found after a system diagnostic test run in the clinic.The patient later returned for more positional testing and low impedance was still found.The vns generator was turned off.System diagnostic results from the implant were provided and showed normal results.The patient reportedly did not have the ability to manipulate the device and there was no reported trauma.X-rays were reportedly taken by the physician and did not show any lead breaks in the lead.Pin insertion was also verified.These x-rays were not evaluated by the manufacturer.The patient returned to the or for a lead replacement.During the surgery, the silicone tubing appeared detached at the lead pin.The surgeon attempted to salvage the generator by removing the lead from the generator, but the septum plug was removed.It was also noted that fluid was found in the generator header.The septum plug removal and fluid in the generator were reported in mfr.Report # 1644487-2017-04472.Both the lead and generator were replaced.A device history record of the lead indicated all quality inspections had been completed and passed prior to release for distribution.The lead and generator have not been received to date.No further relevant information has occurred to date.

Event Description

Further information was received that the fluid found in the generator header reported in mfr.Report # 1644487-2017-04472 was due to the detachment of the silicone tubing.The lead was returned to the manufacturer but product analysis has not been completed to date.No further relevant information has been obtained.

Event Description

Product analysis was completed on the explanted generator.The generator was able to be interrogated and system diagnostics were performed.Lead impedance was and current delivered were normal for all tests performed.A comprehensive automated electrical evaluation showed that the generator performed according to all functional specifications.A review of the downloaded data from the generator showed low impedance was measured before explant.Product analysis was also completed on the lead.The lead was returned in two portions.On one portion, set screw marks were seen on the connector pin indicating proper contact had been made between the set screw and connector pin at one point.Abrasions were seen on the connector boot.A continuity check performed between the connector pin and connector ring verified no connection between the coils existed.The lead connector boot was found to be torn which resulted in a portion of the lead coils being exposed and stretched.The second portion of the returned lead was also inspected.Abrasions were also seen on this portion where tie-downs were once placed.It was verified that no connection between the positive and negative lead coils existed within the returned lead portion.Besides typical cuts, damage, and visual observations associated with implant and explant, there were no visual anomalies found.No further relevant information has been received to date.

• 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: 6874733
• MDR Text Key: 86715187
• Report Number: 1644487-2017-04471
• 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: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/29/2020
• Device Model Number: 303-20
• Device Lot Number: 5115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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: 10 YR