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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Neck Pain (2433); No Code Available (3191)

Event Date 02/24/2017

Event Type  malfunction  

Event Description

It was reported by a company representative that a vns patient had high impedance.The lead impedance at the last appointment in (b)(6) 2016 was reported to be high.Clinic notes were received from a visit on (b)(6) 2017, where the patient experienced a sudden, single, sharp pain in his neck, followed by a rhythmic cough.It was unclear if it was related to vns and the magnet was swiped and the pain stopped but the cough did not stop.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Manufacturer Narrative

Relevant tests, corrected data: the specific diagnostics and settings values were inadvertently not provided in the initial report.

Event Description

Full revision surgery occurred.The explanted devices were reported to have been discarded by the explant facility.

• 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: 6403816
• MDR Text Key: 69908302
• Report Number: 1644487-2017-03377
• 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: 04/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2006
• 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 Outcome(s): Required Intervention
• Patient Age: 13 YR