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

Model Number 103

Device Problems Break (1069); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Undesired Nerve Stimulation (1980); Seizures (2063); Shock from Patient Lead(s) (3162)

Event Date 11/14/2016

Event Type  malfunction  

Event Description

It was reported by the patient that a machine at work had harmed his device, causing the device to not stop shocking him.The patient reportedly went to the er and had his device disabled.The patient reported that he had to disable the device and that he believed he might need a new device.It was reported that it was perceived that the vns device is damaged.No additional relevant information has been received to date.

Manufacturer Narrative

Adverse event or product problem, corrected data: "adverse event" was inadvertently not selected in the supplemental mdr 1.Outcomes attributed to adverse event, corrected data: "other serious" was inadvertently not selected in the supplemental mdr 1.The following statement was inadvertently not reported in the supplemental mdr 1: "the patient emailed the company representative the day after the follow-up appointment and indicated that his epilepsy was worse that day than before he had the vns.He indicated that in the past he had managed his epilepsy with medication, but that now he wasn't using medication." (b)(4).Report source, corrected data: "consumer" was inadvertently not selected in supplemental mdr 1.

Event Description

It was reported through clinic notes of the patient's follow up appointment that the patient experienced mild to moderate choking due to the repeated magnet stimulation caused by the magnets at his place of work and that when he went to the er to have his device disabled, he was sensitive to the lowest settings on the vns.He was prescribed levetiracetam during the visit to the er, but he did not take the prescribed medicine.It was also reported in the notes that the patient experienced an increase in seizures after his device was disabled.The patient emailed the company representative the day after the follow-up appointment and indicated that his epilepsy was worse that day than before he had the vns.He indicated that in the past he had managed his epilepsy with medication, but that now he wasn't using medication.He then told the representative that he was considering a do not resuscitate order.He then emailed the company representative and reported that he was having constant seizures.He said he could barely even hold things in his hands.The patient followed up with the physician, who reported that the increased seizures after the patient was turned back on was not related to vns.It was related to disease progression and due to the patient not taking seizure medication as well as the patient's device being disabled and then programmed back on to sub therapeutic levels.The physician also indicated that stress may be a contributing factor.The patient being barely even able to hold things in his hands was attributed to partial seizure activity.No additional relevant information has been received to date.

Manufacturer Narrative

Device evaluated by mfr?, (b)(4) device evaluation is not necessary because the reported event(s) have been determined as not caused by device failure or to have caused serious injury.

Event Description

The physician indicated that when he disabled the patient's device in the emergency room, he did not realize that the patient though his device was damaged.He only knew that the patient though it was continuously stimulating him.After the patient followed-up with the physician, it was determined that there was no suspected damage or malfunction regarding the vns device.The day of the event, the patient had been working around large magnets used to pick up car parts.The physician reported that he believed the car magnet had been causing the patient's magnet mode stimulation to activate repeatedly, which eventually made the patient not able to withstand the stimulation and request disablement.The patient reportedly didn't feel pain from the stimulation, per say, but it felt like normal stimulation, only constant and stronger, which made him uncomfortable.The physician indicated that they would not be replacing the patient's generator due to this event and that the device disablement was for patient comfort, not to preclude a serious injury.System diagnostics confirmed device function and the patient's battery icon was full at the time of the appointment.The patient's output current was programmed back on to a settings of 0,75 ma.Prior to device disablement, the patient's normal mode output current had been 1 ma.The patient's magnet mode stimulation being activated repeatedly while working near strong magnets is an expected event and is not an indication of device failure.No additional relevant information.

Manufacturer Narrative

Adverse event or product problem, corrected data: "adverse event" was inadvertently selected in the supplemental mdr 1.Outcomes attributed to adverse event, corrected data: "other serious" was inadvertently selected in the supplemental mdr 1.

• Brand Name: PULSE GEN MODEL 103
• 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: 6179527
• MDR Text Key: 62864597
• Report Number: 1644487-2016-02836
• 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: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Model Number: 103
• Device Lot Number: 202868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2014
• 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): Other
• Patient Age: 27 YR