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

Model Number 302-20

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250); High impedance (1291)

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

Event Date 01/12/2015

Event Type  malfunction  

Event Description

It was reported by the physician's office that the patient was referred for a vns consult for an unknown reason and the plan was for vns generator replacement, but a lead replacement may also be needed.No information was initially provided.An implant card was later received showing the patient underwent a full vns revision.The diagnostics for the old device showed high impedance.It was also explained that the lead had visible "holes" and fluid within the silicone tubing.Diagnostics with a new generator and the old lead still showed high impedance.Adequate insertion of the lead pin into the generator was confirmed, but the high impedance did not resolve.The new generator was tested using the resistor pin and confirmed good diagnostics.Upon exposing the electrodes within the neck, it could be seen that one of the electrodes was no longer wrapped around the vagus nerve.Per the anesthesiologist, the patient had been known to have severe falls due to seizure activity and the compromises in the lead may have occurred during one of the falling evens.Once both the lead and the generator were replaced, diagnostics were within normal limits.The explanted generator and lead were reported to be discarded after the surgery.

Manufacturer Narrative

This information was inadvertently reported incorrectly on the initial mfr.Report.

Event Description

The programming history database was reviewed and no anomalies related to the high impedance was noted.Additional information was received from the patient's following physician stating the reason for the vns replacement referral was due to battery depletion and high impedance.Additionally, the physician did not know the cause of the holes, fluid leaks, or electrode detachment from the nerve.

• 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: 6461922
• MDR Text Key: 71840384
• Report Number: 1644487-2017-03571
• 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
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2009
• Device Model Number: 302-20
• Device Lot Number: 200185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2006
• 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: 20 YR