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

Model Number 106

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dysphagia/ Odynophagia (1815); Fatigue (1849); Headache (1880); Muscle Spasm(s) (1966); Pain (1994); Seizures (2063); Blurred Vision (2137); Lethargy (2560); No Code Available (3191)

Event Date 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was initially reported by the by the patient that she was having painful stimulation and increase in seizures, dysphagia, and coughing.It was noted by the physician's office that the patient's increase in seizures were not above pre-vns baseline levels and that simple vns setting adjustments resolved the issues and were not considered as serious injuries.However, the patient called again reported painful stimulation, voice alteration, and the inability to turn vns settings up.Additionally, the patient stated she has a feeling of being hungover for 72 hours after every settings change, which is described as a post-ictal state, including symptoms of blurred vision, headaches, very tired and lethargic.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported by the physician's assistant that they started the titration really slow, but the patient is still having these dramatic reactions and always coughs every time the device is titrated, but the patient states she wants to continue programming the settings up.The patient is determined to get up to 1.5ma because she knows these are getting into the therapeutic level, but the patient is currently still at 1.0ma.The patient's seizures are noted to be about the same as pre-vns baseline levels and the patient is also on multiple medications and medical marijuana.It was noted that some of these issues may be in the patient's head.It was noted system diagnostics are always checked and the device is performing as expected.It was also explained that the patient has these same types of reactions with medication changes, too.It was confirmed the patient has not had any serious injuries and the only interventions which have been taken are setting changes.

Event Description

An additional report was received that the patient's device was explanted.The reason for explant was stated to be the adverse events the patient was experiencing which included migraines, eye twitching, pain from the generator, and heaviness on her ribs.The physician stated the patient could not be titrated up fully as the patient experienced the adverse events when the output current was increased.The patient again reported feeling the "hangover" like symptoms and having an increase in seizures prior to the vns explant surgery.She also stated the vns device never worked for her.Diagnostics were performed and no issues were found and the diagnostics were within normal limits.The surgeon relayed the explant of the generator was for patient comfort and the lead was left implanted.The generator has not been received for analysis to date.

Event Description

The generator was received and product analysis was completed.In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 5889627
• MDR Text Key: 53580441
• Report Number: 1644487-2016-01873
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/05/2019

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: 10/15/2017
• Device Model Number: 106
• Device Lot Number: 4587
• 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
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided; 12/26/2018; 02/08/2019
• Supplement Dates FDA Received: 09/21/2016; 01/18/2019; 03/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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 Age: 47 YR