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

Model Number 302-20

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

Patient Problems Chest Pain (1776); Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2016

Event Type  malfunction  

Event Description

Patient was referred for generator replacement initially.Additional information was received on 11/14/2016 that the patient is to have a full revision surgery.On (b)(6) 2016, patient underwent full revision surgery due to high impedance.The explanted devices were reported to have been discarded.Additional relevant information has not been received to date despite multiple attempts.

Event Description

High impedance was first observed on (b)(6) 2016 from chest x-rays.The chest x-ray revealed a break in the lead.Per notes dated (b)(6) 2016, the patient has had an increase in seizure events (staring, eye-fluttering) and frequent complaints of chest pain since (b)(6) 2016.Patient points to the region of his stimulator as being the area of discomfort.The device is palpable in its submuscular pocket in the anterior left chest wall.Patient does not have any erythema in the chest but does report some tenderness.

• 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: 6183181
• MDR Text Key: 62959484
• Report Number: 1644487-2016-02906
• 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: Physical Therapist
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2006
• Device Model Number: 302-20
• Device Lot Number: 014406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2004
• 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: 16 YR