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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); High impedance (1291)

Patient Problems No Known Impact Or Consequence To Patient (2692); Fibrosis (3167)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

It was reported that a patient's device was found to show high lead impedance.It was noted that if the leads were revised, the generator would also be prophylactically replaced to minimize number of surgeries for the patient.No surgery has occurred to date.No additional relevant information has been received to date.

Event Description

A full revision surgery occurred.It was noted that the patient's replacement lead was implanted on the right vagus nerve due to fibrosis on the left vagus nerve.It is indicated per labeling that fibrosis between the nerve and electrode is a possible cause of high lead impedance.Follow up with the physician's office provided the settings and diagnostics of the patient's device prior to replacement.The system diagnostics indicated high impedance, end of service (eos) = no.No devices were received to date.No additional relevant information was received to date.

Event Description

The patient's explanted devices were returned for analysis.Product analysis was completed for the generator and lead.The generator performed according to functional specifications and analysis of the device found no abnormalities or malfunctions.The explanted lead was returned in five portions.Visual examination of the portions found that the setscrew marks were observed on the connector pin, indicating a proper mechanical contact between the conductive surfaces of both the generator and connector pin, ensuring a good electrical connection with the lead.The quadfilar coil 1 appeared to be broken near the anchor tether.Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being mechanically damaged, with pitting and residual material.Pitting was observed on the coil surface, and was likely related to stimulation present for a certain period of time.No other anomalies were noted.Based on the findings from product analysis, there was evidence to suggest a discontinuity in the returned portions of the device.Note that since the positive and negative electrodes were not returned, no analysis could be performed on those portions of the lead.No additional relevant information has been received to date.

• 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: 7326901
• MDR Text Key: 102086346
• Report Number: 1644487-2018-00352
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2005
• Device Model Number: 302-20
• Device Lot Number: 7763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2003
• 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: 32 YR