MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Device Sensing Problem (2917)

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

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the vns patient's device was unable to verify heartbeat detection during an office visit on (b)(6) 2016.Using heartbeat sensitivity level 1 to 5, the device could not displayed heartbeat but it showed bpm - ?????.It was reported that the device was implanted in (b)(6) 2016 but the pre-surgical evaluation could have not been performed.It was reported that they could interrogate the device and the system diagnostic test was ok on the office visit on (b)(6) 2016.It was reported that the tablet device and the wand was functioning properly and the autostim was disabled.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.Additional information was received indicating that the patient's generator is located in the chest at 9cm from the lead placement.It can not be confirmed that the heartbeat verification was performed the day of implant.No additional information was provided to date.

Event Description

Memory data extracted from the patient's device were provided to the manufacturer and reviewed.They indicated the following: on (b)(6) 2016, heart rate was initially unable to be sensed by the generator.However, once the device was interrogated at sensitivity 4, a foreground heart rate of 90.1 bpm was detected.When the patient came back on (b)(6) 2016, it appears that there was again evidence of heart rate (82.7 bpm).Given this information, it appears that the generator was able to accurately sense at higher sensitivity levels (4-5).However, one reason why the programmer may not have been able to display the value (showed ????) on (b)(6) 2016 could be because the output current was programmed on, which is known to interfere with picking up this value during stimulation.It appeared also that on (b)(6) 2016, the settings were tested on 2 and 5 with outputs disabled.At this time, however, based on the information we have the generator was at least intermittently sensing.

• Brand Name: PULSE GEN MODEL 106
• 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: 5927512
• MDR Text Key: 54536233
• Report Number: 1644487-2016-01996
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

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: Lay User/Patient
• Device Expiration Date: 09/22/2017
• Device Model Number: 106
• Device Lot Number: 4536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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