MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Invalid Sensing (2293); Device Sensing Problem (2917); Output below Specifications (3004)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a company representative on 09/27/2016 that they were at a dosing appointment with the patient and that the magnet was swiped two times, and the patient coughed during both of the magnet swipes.This made the physician and patient believe the magnet activated stimulation.The company representative then interrogated the device with her own tablet, however the magnet activations screen showed that the last magnet swipe was in (b)(6) of 2016.The company representative confirmed that the date on her tablet was set to (b)(6) 2016 and also stated that they waited for the magnet stimulation to be completed before interrogating the device.A magnet diagnostic test was performed by having the patient swipe the magnet, and then the ok button was pressed on the programmer.The screen reported ¿the pulse generator did not sense a magnet swipe.¿ the patient stated she didn¿t feel the stimulation or have a cough.The company representative tried a magnet mode diagnostics again, this time waiting to press ok until the patient coughed.Again the screen reported ¿the pulse generator did not sense a magnet swipe.¿ the magnet on time was reported to be 60 seconds and the output current was higher than both autostimulation and normal mode.The patient did not cough or feel stimulation with normal mode.It was reported that when the patient came in today, the autostimulation output current was lower than normal mode and they had just adjusted the autostimulation up to be between the normal and magnet mode, so it was unclear if the patient coughed or felt the stimulation with autostimulation.It was reported the patient was swiping the magnet slowly across her chest so that the magnet was there for about 2 seconds.The company representative stated that when the patient swiped the magnet, she could see the patient sense something and then would hear the patient cough after the magnet swipe.The patient was advised to swipe in a cross pattern.The generator was then interrogated and no magnet swipes were sensed.It was stated the patient doesn¿t use the magnet very often.The magnet swipe was then attempted using a different magnet and tried interrogating with the physician¿s tablet, which then showed the last magnet swipe activation was still in (b)(6) 2016 and no swipe was recorded.A few times on the call, the patient tried to swipe the magnet and didn¿t cough.They continued to swipe the magnet until she did cough though.The company representative stated it looked like the patient¿s swiping technique was correct.Review of the decoded data was performed 10/24/2016.Programming data was reviewed.The battery voltage on (b)(6) 2016 was 2.891 and shows ifi-no.The impedance recorded shows 1804 ohms.Total magnet swipes show a count of 34, and the magnet swipe counter did not increase during the timeframe of the visit.The two magnet diagnostics which were attempted resulted in a fault, and were not successful.The seizure detection settings were programmed on.The foreground heartrate shows the device was sensing the patient¿s heartrate.Additional relevant information has not been received to-date.

Event Description

Follow-up from the company representative who attended the patient¿s next visit on (b)(6) 2016 confirmed that during the visit magnet swipes were performed and the tablet was reading correctly.Upon further questioning, the patient states that she ¿swipes her magnet every day¿, however, further conversation lead her to say that she doesn¿t swipe the magnet.It was stated the reason the patient states she swipes it everyday is that her mother is present during the conversations regarding magnet usage.The parameters were adjusted for the magnet and it was swiped twice.After interrogation, both magnet swipes registered on the tablet.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 6059491
• MDR Text Key: 58616173
• Report Number: 1644487-2016-02480
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 11.0.4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR