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

Model Number 302-20

Device Problems Corroded (1131); High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problems Neck Pain (2433); No Information (3190)

Event Date 10/01/2015

Event Type  malfunction  

Event Description

Product analysis was completed and approved for the lead on 11/11/2016.Scanning electron microscopy images of the connector pin show that pitting or electro-etching conditions have occurred on the pin surface.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.The lead coils have a spiral/wavy appearance in some locations.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.Product analysis for the generator was completed and approved on 11/15/2016.In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.From the data dump, the patient's pre change diagnostics from (b)(6) 2016 show high impedance of 5359 ohms with a post change of 2627 ohms.This is indicative of intermittent high lead impedance.

Manufacturer Narrative

Adverse event, corrected data, initial mdr omitted information that was known prior to submission of the initial mdr required intervention to prevent permanent impairment/damage, corrected data, initial mdr omitted information that was known prior to submission of the initial mdr describe event or problem, corrected data, initial mdr omitted information that was known prior to submission of the initial mdr.

Event Description

The patient experienced painful stimulation in the neck after the patient was choked in 2015.The patient's replacement surgery was scheduled for this painful stimulation for patient comfort only.Since the date that the high impedance first occurred is unknown, it is possible that the high impedance contributed to the patient's painful stimulation.

• 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: 6149620
• MDR Text Key: 61863510
• Report Number: 1644487-2016-02804
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2007
• Device Model Number: 302-20
• Device Lot Number: 011718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2005
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR