MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Dysphagia/ Odynophagia (1815); Edema (1820); Muscle Spasm(s) (1966); Muscle Weakness (1967); No Code Available (3191)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was experiencing an increase in seizures due to lowered vns settings.The increased myoclonic seizures were causing headaches, inability to focus, sore and tight muscles and sleeping issues due to the constant movements.The patient stated that the generator tested ok, but questioned if there could be issues with the generator.The patient stated that in february, the patient was admitted to the hospital as the physicians were concerned that the patient was having a stroke due to the patient's face muscles drooping, voice changes, and chest pains.After vns settings were lowered, the symptoms resided, and then further tests were performed confirming that there was no stroke.The patient reported their neck was twitching and was swelling, and there was severe issues with talking.No additional, relevant information was received to date.

Manufacturer Narrative

Date received by manufacturer, corrected data.Initial report inadvertently listed aware date to be 04/12/2019 instead of 04/09/2019.

Event Description

Clinic notes were received noting that the patient was having problems with swallowing, coughing, voice alteration, and some swelling in her neck.The patient believed these to be due to vns, so the device was turned off.The patient also went to see a neurosurgeon who recommended against changing the vsn due to a high risk of complication.It was also stated in the notes that the patient responded well to vns, which helped control her seizures.No additional relevant information was received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 8557527
• MDR Text Key: 143308428
• Report Number: 1644487-2019-00809
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/05/2017
• Device Model Number: 105
• Device Lot Number: 203240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR