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

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoxia (1918); Convulsion, Clonic (2222)

Event Date 12/18/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced breathing issues with low oxygen.The patient was referred to a pulmonologist to confirm the reported events.The patient reports experiencing multiple hypoxia events which resolved by itself without any intervention.Information received from the physician noting that when the patient was set to normal 1ma/magnet 1ma/ autostim 1.25ma they experienced one event of hypoxia 75% without a seizure and 2 events of seizures with hypoxia.When set to normal 0.75ma/magnet 0.75ma/ autostim 1 ma they experienced a seizure with low oxygen, 89%.When set to normal 0.25ma/magnet 0.25ma/ autostim 0.25 ma they experienced a low oxygen 50% event with no seizure.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

Additional information received noting that the patient underwent a sleep study and she experienced a decrease in o2 saturation.The patient also reports that her seizure frequency is less, but it seems that when she has a breakthrough seizure, they are more intense, but she is able to recover more quickly.The physician just notes that the patient has anxiety (not alleged against the vns) but never had hypoxia triggered by anxiety.The physician would like to stay on the current medication and vns settings until theyre able to resolve the hypoxia issue, no additional intervention was noted.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18544756
• MDR Text Key: 333264839
• Report Number: 1644487-2024-00061
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106
• Device Lot Number: 834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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: 30 YR
• Patient Sex: Female