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

Model Number 300-30

Device Problems Use of Incorrect Control/Treatment Settings (1126); Human-Device Interface Problem (2949)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271); Depression (2361)

Event Date 10/01/2015

Event Type  malfunction  

Event Description

It was reported that a vns patient does not feel stimulation and has an increase in seizures and depression.The physician increased the patients settings from 1.75ma and 130us to 3.0ma and 500 us, and the patient still could not feel the stimulation.It was noted the patient's abilify was increased.The patient has been referred for full revision.Clinic notes from a visit on (b)(6) 2015 received for full revision referral were received which indicated that the physician stated the patient is not receiving current even after "doubling current and tripling pulsewidth" and suspects that the lead may not be attached to the nerve.It was reported that the patient does not feel the stimulation in normal or magnet mode and can feel an increase in feeling like seizures are coming on but is unsure if they actually occurred.Lead impedance and generator battery life were reported to be fine.The settings were reported to be increased current from 1.75ma with pulse width of 130us to 3.0ma with pulse width of 500us and she did not feel it at all and no voice change.The settings were set back to the original settings except the output and magnet current were increased.The patient is requesting that the generator pocket be moved at surgery because it is itchy.No additional relevant information has been received to-date.No known surgical intervention has occurred to date.

Event Description

The generator and lead were explanted on (b)(6) 2015.Follow-up to the explant facility indicated that the facility does not keep any explants and they are discarded in surgery.

Event Description

An implant card was received indicating the reason for replacement as the device was ¿non functioning.¿ follow-up to the physician by the company representative revealed that the diagnostics on the device were reportedly good but due to the patient¿s symptoms and wish for a newer model the doctor decided to replace the lead and generator as the patient¿s previous lead would not be compatible with the newer model device.The patient was reported to be doing well after the surgery, and no trauma was noted.

• Brand Name: BIPOL 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: 5232626
• MDR Text Key: 31725410
• Report Number: 1644487-2015-06477
• 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: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2002
• Device Model Number: 300-30
• Device Lot Number: 33130C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2016; 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2000
• 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: 27 YR