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

Model Number 106

Device Problem Energy Output Problem (1431)

Patient Problems Undesired Nerve Stimulation (1980); Seizures (2063)

Event Date 07/15/2019

Event Type  malfunction  

Event Description

It was reported that there is concern surrounding the patient's auto stimulation.It was reported that at an appointment on (b)(6) 2019, the physician noticed that the auto stimulation was disabled and noted that the patient informed of an increase in auras during the 2 weeks following up to that appointment.The patient then called the physician on (b)(6) 2019 informing that they felt their device activating 10 seconds on and 10 seconds off through the date range of (b)(6) 2019 - (b)(6) 2019.The programming data was reviewed and a disablement was observed on (b)(6) 2019, which occurred directly after the initial interrogation.Data supports that the generator was delivering intended therapy up until the device interrogation on (b)(6) 2019.Additionally, it appears that at the time of disablement, the physician programmed the device right back on to intended therapy settings, therefore there is no concern for an interruption in therapy at this time.It was confirmed that no "reset" codes were triggered at the time of this event.No high impedances and no anomalies were observed in the programming data.No other relevant information has been received to date.

Event Description

Further follow up confirmed that the physician was not sure why the patient had an increased perception of vns stimulation, but was able to clarify that the patient's increased aura's were likely stress related and non-epileptic.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 9265708
• MDR Text Key: 164839837
• Report Number: 1644487-2019-02123
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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
• Report Date: 12/11/2019

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: 08/02/2018
• Device Model Number: 106
• Device Lot Number: 203912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2016
• 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: 39 YR