MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Energy Output Problem (1431)

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

Event Date 01/01/2019

Event Type  malfunction  

Event Description

It was reported that the patient's vns generator was not programmed on despite the physician believing that she had programmed it on at one point.It was stated that the physician was previously able to interrogate the generator, but unable to program it.The patient was implanted in a separate territory in the state and, per the current company representative, the patient did not attend the follow up appointment and moved to the current location.Tablet data was received from the date of implant and no anomalies or indications of a reboot were noted.No additional relevant information has been received to date.

Event Description

The tablet export data for the generator was reviewed by the manufacturer.There was no indication of a reboot and all output currents were found to be programmed off.The impedance was within normal limits.It was revealed that the last reboot would have been related to the manufacturing process and was unrelated to the investigation.High impedance was found to be present in the history log and was reported in mfg.Report #1644487-2019-01748.Based on the review, there was no indication of a reboot (last reboot in data was during manufacturing) or other events that had changed the programmed parameters due to the limited data received.Follow up with the physician's office revealed that the patient has been seen at least 4 times, is doing well, and the output currents are working well.There was no evidence to link the high impedance and the reported unexpected settings change.

Event Description

It was reported by the physician that she was having difficulty with detecting the generator, but was able to eventually program the vns.The physician expressed the desire to replace the vns generator.The tablet data was received and the decoder was reviewed by the manufacturer.Review of the data revealed that the difficulty in communicating with the generator was likely related to emi.It appears that a programming event did occur at some point between the date of implant and the date of the initial report as it was found that the autostim on time was programmed from 60 seconds to 30 seconds.However, there was no indication of any other programming changes nor of a generator reboot.No relevant surgery is known to have occurred to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8809139
• MDR Text Key: 151648693
• Report Number: 1644487-2019-01418
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2020
• Device Model Number: 1000
• Device Lot Number: 204563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2018
• 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: 22 YR