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

Model Number 302-20

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

Patient Problem No Code Available (3191)

Event Date 05/19/2016

Event Type  malfunction  

Event Description

It was reported on 05/23/2016 that this patient's device is showing high lead impedance.The lead has been implanted since 2007 but the generator has only been implanted since (b)(6) 2015, so until x-rays or surgery occurs, it is unknown if pin insertion is the cause of the high impedance or a lead fracture.The patient has not yet had x-rays although they are requested.No surgical intervention has occurred to date.

Event Description

Clinic notes were received on 10/27/2016.Notes mention the broken lead and that the patient has decreased tolerance for stimulation.Surgical intervention has not occurred to date.

Event Description

It was indicated that the decreased tolerance in stimulation was reported to be painful stimulation at the patient's neck.

Event Description

On (b)(6) 2017 an implant card was received indicating that the patient had a full replacement on (b)(6) 2017.Explant products have not been received to date.

Event Description

The explanted devices were discarded after explant and are not available for analysis.

• 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: 5720883
• MDR Text Key: 48211945
• Report Number: 1644487-2016-01328
• 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,Followup,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2010
• Device Model Number: 302-20
• Device Lot Number: 1892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2007
• 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: 20 YR