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

Model Number 302-30

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 02/01/2016

Event Type  malfunction  

Event Description

It was reported that in (b)(6) 2016 the patient reported erratic stimulation.It was reported that in (b)(6) 2016 the patient reported that he had fullness in his head, continuous stimulation for 2 hours, voice hoarseness, and painful stimulation.The patient reported that it started when he turned his head a certain way, and demonstrated it to the physician.Due to these symptoms, the patient's device was disabled in (b)(6) and the patient was referred for generator replacement surgery.After disablement, the patient continued to report feeling intermittent stimulation, pressure in his head, and painful stimulation.The patient reported that when he turns his head, he can feel his voice change and stimulation, despite the fact that the output currents were off.The painful stimulation was reported as occurring in the neck and the head.Impedance was reported to be normal at 1171 ohms.A review of ap chest x-rays identified a potential lead fracture located on the upper left side of the generator.The treating physician also believed that there was a lead fracture.There was no known trauma or manipulation at the site of the fracture.The patient has had anxiety in the past, and this was indicated by the physician as a possible reason for the patient's symptoms post-generator disablement.No additional relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

Further programming/diagnostic history from the physician's tablet was reviewed.All reported impedance values were within normal limits.Internal data was reviewed and found that, given the small values of impedance, the changes in impedance detected could be normal.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

• 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: 5980471
• MDR Text Key: 56038748
• Report Number: 1644487-2016-02178
• 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
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2004
• Device Model Number: 302-30
• Device Lot Number: 6575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2002
• 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: 75 YR