MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Seizures (2063); No Code Available (3191)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the physician's office that they suspected that the patient's vns electrodes were loose as the patient was not perceiving stimulation.However, the physician reviewed x-rays and lead detachment was not observed.It was noted that at an appointment, the patient did not perceive normal or magnet mode stimulation.It was reported that the output current was increased all the way and the patient felt nothing.It was unclear what the office meant by "all the way." it was noted that the patient typically experiences slight hoarseness, but did not have any when turning the device up, which lead to the suspicion that there was a lead break or loose leads.The patient's seizures seemed worse at the time that the patient reported not feeling stimulation.The patient's friend noted seeing a bruise at the vns electrode site several days prior to an appointment and the physician noted that there was a bruise at the generator site.The physician's office mentioned that the patient normally experiences severe drop seizures and has multiple in a day.Follow up with the company representative revealed that the representative had seen the patient and diagnostics were within normal limits.The patient's vns settings were low and she could not feel stimulation, even with a magnet swipe.The patient reported that the vns worked for a while, but she experienced a recent increase in seizures.The x-rays have not been received by the manufacturer to date.No additional relevant information has been received to date.

Event Description

Follow up with the physician's office revealed that the reference to increasing the output current "all the way" was to 1.00 ma per protocol.It was stated that the patient could not feel the stimulation as she had previously and that the patient could not feel the 1.50 ma magnet stimulation.It was reported that the increase in seizures was just the same as before the vns.The bruising was thought to be the result of a seizure.It was stated that the physician thought that the increase in seizures were due to the electrodes not being connected well.The physician believes that a seizure may have caused electrode detachment and the patient was sent for evaluation, despite the diagnostics showing as within normal limits and detachment not being verified in x-rays.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7176252
• MDR Text Key: 96820875
• Report Number: 1644487-2018-00048
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/07/2018
• Device Model Number: 106
• Device Lot Number: 5053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2016
• 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 Age: 56 YR