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

Model Number 300-20

Device Problem High impedance (1291)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 10/01/2015

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2015 that this patient is experiencing painful and erratic stimulation at an unspecified location.The pain only occurs at night for the patient.At a recent clinic visit high impedance was found on system diagnostics.The patient denies any incident that may have caused the high impedance.The physician was instructed to turn off the device or lower the device settings.The patient will likely receive a m106 to replace her existing system.Clinic notes state over the past month or more she has been having intermittent sensations of her device going off where as she had not really felt it come on at all in the past year.When she swipes her magnet she has no stimulation.Surgery is likely but has not occurred to date.

Event Description

The explanted devices were discarded after surgery and will not be received for analysis.

Event Description

The patient had a full replacement on (b)(6) 2015.The explanted devices have not been received for analysis to date.

Event Description

The patient reported muscle spasms (a fluttering feeling) in her neck and down into her left shoulder which the patient states began around the time of the high impedance.

• 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: 5232625
• MDR Text Key: 31748364
• Report Number: 1644487-2015-06480
• 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
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2003
• Device Model Number: 300-20
• Device Lot Number: 4309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2001
• 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: 46 YR