MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Device Displays Incorrect Message (2591)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 06/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was having a lot of trouble with the battery.The patient reported that she was seen by the physician two weeks prior at which time the generator battery showed as "dead".The patient also reported that the physician lowered the device settings.The patient reported that she feels that she is being electrocuted constantly which began approximately a week and a half prior.The patient placed the magnet over the generator to disable stimulation; however, reported that she was still able to feel stimulation.The patient's neurologist wants to replace the generator due to the patient complaining of erratic stimulation.The patient was seen by the surgeon and it was reported that device diagnostics were within normal limits and the device was not at end of service.It was reported that the pain is limited to the patient's chest.The patient's generator was programmed off which did not resolve the patient's pain.The patient indicated that when she presses on the lead at the generator site the patient resolves.No known surgical interventions have been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

The physician reported that the cause of the electrocution sensation is unknown since the event occurs without device stimulation.It was reported that the patient was scheduled for vns replacement.It was reported that the patient feels the shocking when she presses on the lead and this resolves the pain.Clinic notes dated (b)(6) 2015 note that the patient is having problems with the vns shocking her non-stop.Clinic notes dated (b)(6) 2105 note that the vns is still shocking the patient on the lowest setting.It was noted that the plan is to move the generator to the left scapular area.Surgery is planned, but has not occurred to date.

Event Description

The patient was scheduled for surgery; however, was unable to undergo surgery due to testing positive for meth and marijuana during pre-operative testing and anesthesia cannot be done.It was reported that is it unknown whether or not the surgeon will reschedule the surgery.

Event Description

The surgeon reported that the patient picked through the skin to access the lead and cut the lead.It was reported that the surgeon will not likely see the patient again.

Event Description

It was reported that the patient was scheduled for surgery, but later reported that the surgery had been cancelled and postponed until further notice due to the drug abuse by the patient.Clinic notes dated (b)(6) 2015 note that the patient was see in the emergency department and when no neurologists were available the patient cut the protruding lead wire out herself.The patient noted since first noticing the wire she was being shocked 24/7.It was reported that due to the patient's non-compliance the surgeon will no longer see the patient.The patient will need to be seen by another surgeon.The patient continues to complain of painful stimulation.Clinic notes dated (b)(6) 2016 note that the physician called the patient to explain why he was uncomfortable redoing the vns.The patient had positive drug screens within a week and failed to have a third done a month later.The patient dug into the electrodes under her chest wall skin, pulled the electrode out and cut it off.The patient continued to complain of shocking in the neck and the left side of her chest, even when the generator was programmed off.The surgeon indicated that he does not feel she will be happy after replacing the unit and electrodes, even if the generator is relocated to her suprascapular area where she can no longer dig at the electrodes.

Manufacturer Narrative

Event Description

It was reported in (b)(6) 2018 that the patient's system diagnostics were within normal limits.The physician indicated that the patient had not had a revision to replace the lead since the report of the patient cutting her lead.Therefore based on the available information, it appears unlikely that the patient cut her lead.A review of the manufacturer's programming history database also found information that the patient's generator had not been programmed off except during office visits for less than a day.The patient's generator was on despite the surgeon saying her device was off.The database also showed that a low output current was observed on (b)(6) 2015, but impedance was within normal limits.The generator was programmed to 3.25 ma but was only delivering 3.0 ma.Through ohm's law calculation, it was determined that this was due to the programmed setting, in conjunction with the impedance value, being above the capabilities of a normal functioning generator.This is an expected event for some generators that are programmed to high output current.However, this is likely why the patient reported that her physician said that her generator was no functioning correctly and was "dead." no device failure is suspected.

• Brand Name: PULSE GEN MODEL 105
• 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: 4949640
• MDR Text Key: 23151179
• Report Number: 1644487-2015-05357
• 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: Followup,Followup,Followup,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/05/2016
• Device Model Number: 105
• Device Lot Number: 203191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• 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: 35 YR