MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 300

Model Number 300-20

Device Problem Fracture (1260)

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

Event Date 11/03/2016

Event Type  malfunction  

Event Description

It was reported that the patient's vns registered high lead impedance.The patient did not mention any trauma, and the chest x-ray as-reviewed by the treating physician did not reveal a clear lead fracture.The output current was set to zero, and the patient was referred to neurosurgery.Surgical intervention has not occurred to date.An ap chest x-ray image was reviewed by the manufacturer.The generator appears to have been placed normally per labeling.Both connector pins of the lead appear to be fully inserted inside the connector block.The feedthru wires both appear to be intact.No obvious fractures or sharp angles were noted.However, based on the quality of the image provided and only having one view, it was difficult to assess all portions of the lead for gross fractures or sharp angles.Both lead wires appear to be intact at the connector pins.A portion of the lead appears to be behind the generator and could not be assessed.The presence of a micro-fracture and/or a lead discontinuity with the portion of the lead behind the generator could not be ruled out.No additional pertinent information has been received to date.

Event Description

The patient¿s full vns replacement surgery was completed.The explanted lead and generator were received by the manufacturer and are undergoing product analysis.No additional pertinent information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the returned generator.Visual examination showed only observations consistent with the explant process.This also includes an observation of burn-marks, consistent with electro-cautery at the time of device explant.No surface abnormalities were noted on this device.A pulse-disabled warning message and vbat

• Brand Name: LEAD MODEL 300
• 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: 6390340
• MDR Text Key: 69440212
• Report Number: 1644487-2017-03349
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2000
• Device Model Number: 300-20
• Device Lot Number: 12088C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/1998
• 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: 41 YR