MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Kinked (1339)

Patient Problems Headache (1880); Pain (1994); Seizures (2063); Electric Shock (2554)

Event Date 03/01/2013

Event Type  Injury  

Event Description

It was reported that the vns patient was complaining of pain at the generator site.It was not tied to any cycle, and the mother stated it occurred randomly.It was noted that the patient was intellectually disabled.He had an x-ray that radiology thought looked like a kink in the lead, but the surgeon did not think so.The pain resolved when the device was turned off.The surgeon programmed the device to the lowest settings, and the pain returned.At the (b)(6) 2013 visit, the patient gave the impression that the pain occurred when he was handling other electronic devices (dvd player, handheld electronic devices) and receives a shock in his hand.This then was followed by pain at his device.The mother stated that the pain had lasted as long as 10 minutes or until she put a magnet over the generator.None of his parameters would give him 10 minutes of stimulation.The neurologist speculated if some static shock was leading to some fault in the vns programming.The neurologist increased the output current in the office, and the patient had no complaints for the 20 minutes he was there.The patient was seen again on (b)(6) 2013.The pain was better, but they pinpointed the pain occurring whenever he plugged a device into a power outlet.They no longer permitted him to do this.Otherwise he was tolerating his device settings well.The neurologist interrogated the device and noted that he has had 658 magnet activations since implanted in (b)(6) 2012, but the last activation appeared to have been on (b)(6) 2013.Notably, he has had a few episodes of pain since i last saw him on (b)(6) 2013.The output current was increased because he was still having multiple generalized convulsions weekly, which he tolerated.However, the neurologist was still concerned that the patient would have pain in the context described.The neurologist also noted that the patient tolerated the device fine as long as he was not plugging in some other device.The episodes had decreased in occurrence by avoiding plugging in objects.Additional information was received stating that the patient was seen in the (b)(6) 2015.The patient was experiencing painful stimulation at the generator and electrode sites as well as headaches.The neurologist believed that the patient¿s lead was kinked based on x-ray images.The patient underwent surgery on (b)(6) 2015 to explant his device.The explanted device has not been returned to date.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative

Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date.Event description; corrected data: the previously submitted mdr inadvertently did not include the information provided by the nurse.Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description

Information was received from a nurse at the neurologist's office.She indicated that the patient had pain near the vns site and had not complained of headaches.The pain started around (b)(6) 2013.The pain is related to vns and started after blood pressure cuff over chest near vns device.The pain was not associated with the duty cycle.The pain always stopped when magnet was taped over vns.The device was explanted because there is not a recurring benefit from device (initially there was) and due to pain.Explant of the lead was up to the surgeon.It is unknown if the lead was explanted.There is a plan for replacement.X-rays were received from the neurologist's office and reviewed by company representatives.One ap and one lateral view image was taken which included the lead and generator in each.The lateral image was unable to be assessed due to the image quality.The ap image was reviewed.The generator was placed normally in the left chest.The lead pin was fully inserted inside the connector block, and the filter feed-thru wires appeared fully intact.A short portion of lead was located behind the generator.The area of the electrode site could not be assessed as the angle of the image overlaid the wires such that the separate lengths of wire could not be distinguished.In the lead portions that could be visualized, there were no gross fractures or discontinuities observed.Based on the x-rays received, the cause for the reported pain and painful stimulation cannot be determined.There was nothing seen that would indicate there was any damage to the generator or lead, leading to a pain scenario.However, the presence of a micro-fracture in the lead or abraded insulation cannot be ruled out.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4859662
• MDR Text Key: 18890987
• Report Number: 1644487-2015-04959
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2014
• Device Model Number: 103
• Device Lot Number: 202198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2012
• 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: 17 YR