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 Syncope (1610); Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a cardiologist that a vns patient was experiencing syncope and her blood pressure was stated be "bottoming out".The physician stated that when the patient stands up or lies down, they have a spell intermittently which drops their blood pressure from 180/100 to 100/80.The physician desired the vns to be disabled to see if the adverse events were related to stimulation.Further information was received that the patient is having severe side effects, specifically uncomfortable twitching at the generator site, slowing heart rate, and dropping blood pressure.It was stated that when the generator was disabled with the magnet, the adverse events ceased.Clinic notes were received for the patient's referral for explant as her cardiologist and neurologist had determined that vns was contributing to her cardiac issues.Clinic notes were received for the patient's referral for explant as her cardiologist and neurologist had determined that vns was contributing to her cardiac issues.Clinic notes stated that the patient is having issues with her vns misfiring, and states that she has been experiencing low blood pressure, syncope episodes.The cardiologist advised to have the vns turned off.The patient has experienced several seizures since having the vns disabled by the magnet but the disablement has lessened the patient's syncope episodes.The cardiologist does not believe that her symptoms are coming from her heart but the vns unit.It was stated that the vns has been disabled at this time.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Manufacturer Narrative

Unique identifier (udi) #, corrected data: initial mdr inadvertently submitted incorrect udi number.

Event Description

Information was received that the patient is referred for explant.In clinic notes, it was reported the patient had paralysis from implant.It also reported that patient reports increase hearing difficulty due to implant surgery.It was stated the vns was not very beneficial but the patient's husband stated vns did abort some seizures and her seizures have increased since vns was turned off.It was also stated the patient had low blood pressure and syncope with intervals between 1-5 minute episodes.The cardiologist assessed this to be due to vns and recommended explant.Using the magnet to disable stimulation helped with syncopic events.The patient also reported she believes the vns is misfiring.No additional 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: 8884891
• MDR Text Key: 154018175
• Report Number: 1644487-2019-01558
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 0542502575006
• UDI-Public: 010542502575006
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2019
• Device Model Number: 106
• Device Lot Number: 204207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• 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): Required Intervention
• Patient Age: 47 YR