MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Mechanical Problem (1384)

Patient Problem Seizures (2063)

Event Date 11/08/2018

Event Type  malfunction  

Event Description

It was reported that programming system "error code 254: apply changes interrupted" was observed when trying to enable autostimulation on a patient.No other functional issues with the generator or programming system were reported.It was noted that the patient's normal and magnet mode stimulation were programmed without issue; heart rate detection was enabled for the patient.The patient was seen back in clinic and the same error code was received with two of the clinic tablets as well as the company representative's tablet.It was stated that the patient was cooperative and has a high level of function so there was no unintentional movement of the wand positioning.The programming wand was held appropriately over the generator while attempting to program the patient however the error continued to appear.It was noted that the representative was able to disable and re-enable autostimulation, but could not change parameters.The patient was seen again for an emergency visit as she was no longer able to feel magnet mode stimulation.The company representative attempts magnet mode diagnostics and increasing magnet mode settings, but kept receiving error code 254.It was clarified that he was able to interrogate the device and pull up the patient's parameters.Impedance was showing to be within normal limits.However, when trying to change any settings, the error code would appear.It was reported that the patient was beginning to experience an increase in seizures and would be looking to replace the device if settings could not be adjusted.It was further noted that the patient used to inhibit stimulation a "significant" amount as the patient had voice alteration with stimulation.However, after (b)(6), she had stopped inhibiting stimulation so often because she realized she no longer had voice alteration and believed she had just grown accustomed to the stimulation.Multiple troubleshooting steps were performed at this visit but programming attempts were unsuccessful.Tablet data was received and reviewed and the programming issues were determined to likely be related to a "stuck" reed switch.No additional relevant information was received to date.

Event Description

At the patient's follow up appointment, the suggested troubleshooting steps were followed.The magnet was swiped several times in succession, but the device still could not be programmed.Then the generator was reset, and the device was now able to be programmed but now showed "low impedance".The patient reportedly still could not feel stimulation.It was discussed that the low impedance may be a "false" display as a result of the output current not being delivered.Replacement surgery was scheduled.No confirmation that surgery occurred was received to date.No additional relevant information was received to date.

Event Description

Product analysis was completed for the returned generator.It was confirmed through product analysis that the reed switch was stuck closed.Bench testing verified that the reed switch would stick after a magnet was applied.The gauss that was measured over the reed switch was between 5.5 and 6.0 gauss, which exceeded the drop-out specification that a closed reed switch must open by (drop-out requirement of 5 gauss).Review of the magnet status indicated 177 magnet holds, 1006 magnet swipes, which would indicate that the reed switch was stuck closed.The generator was subjected to and completed a final electrical test the generator failed magnet detection.No additional, relevant information was received.

Event Description

The patient reported from a call that she felt her emotions were "10 times out of wack" and was experiencing increased seizures.She stated that her medicine was increased, but wanted to know if this would be a normal side effect of vns.An implant card was received indicating that the patient' generator was prophylactically replaced.It was confirmed that the device would be returned for analysis.No device has been received to date.No additional, relevant information was received to date.

Event Description

The explanted device was received for analysis.Analysis has not been completed to date.No additional relevant information was received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8127578
• MDR Text Key: 129173708
• Report Number: 1644487-2018-02201
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/18/2020
• Device Model Number: 1000
• Device Lot Number: 204557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2018
• 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 Outcome(s): Other
• Patient Age: 27 YR