MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Loss of Power (1475)

Patient Problem Seizures (2063)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a vns patient was having an increase in seizures and his medications are being increased as a result.His vns was increased to 1.75ma.It was later reported on (b)(6) 2016 that the patient stated feels that his vns is going off every few minutes due to the auto-stimulation.Follow-up from the patient provided that it was decided to turn off the autostimulation and hr detection and see how it does.The vns was also turned down to the original setting of 1.25ma.A call was received from the patient on (b)(6) 2016 reporting he is still having increased seizures.Additional relevant information has not been received to-date.

Event Description

Follow-up from the company representative who attended the patient's next clinic visit provided that the patient was not able to feel stimulation unless he pushed on the electrodes.The patient's seizures had increased.Lead impedance after diagnostics were within normal limits.Three more diagnostics were performed with the patient's head in different positions.In the positions turned to the right and to the center the impedance was within normal limits, but with the head turned to the right high impedance was found.X-rays were taken and reportedly didn't show any issues.The patient was scheduled for revision surgery on (b)(6) 2016.During the surgery, the surgeon identified that the lead pin had not been tightened.The pin was inserted, but the set screw was loose.After the lead pin was tightened, the 106 generator was interrogated, and the high impedance resolved.The battery showed the generator was at near end of service.The patient had been feeling erratic stimulation at his electrode site since (b)(6) 2016, and they believed it was due to the incomplete pin insertion.The old 106 was explanted because due to the low battery.The generator was replaced and diagnostics were performed in multiple positions to ensure that there was not an intermittent lead issue.The impedance was good throughout the diagnostics.The explanted device has not been received by the manufacturer to-date.

Event Description

The explanted device was received 11/08/2016.Analysis is underway, but has not been completed to-date.

Manufacturer Narrative

(b)(4).

Event Description

Analysis was completed for the returned generator.No obstructions were observed in the pulse generator header lead cavity or the connector blocks.The pulse generator header lead cavity was tested and was within specification requirements.Review of the downloaded data shows high impedance on (b)(6) 2016 with an impedance value of 5,475 ohms.The results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified.The device output signal was monitored while the pulse generator was placed in a simulated body temperature environment and showed no signs of variation in the output signal demonstrating the expected level of output current.Electrical evaluation showed that the pulse generator performed according to functional specifications.The downloaded data showed 4.498% of the battery had been consumed with a voltage of 3.294 volts.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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: 5950882
• MDR Text Key: 54748803
• Report Number: 1644487-2016-02081
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2016

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: 12/09/2017
• Device Model Number: 106
• Device Lot Number: 203688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/17/2016; 12/04/2016; 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2016
• 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: 53 YR