MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Fatigue (1849); High Blood Pressure/ Hypertension (1908); Undesired Nerve Stimulation (1980); Pain (1994); Seizures (2063); Dizziness (2194)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient experienced dizziness ever since the vns was programmed on and that the dizziness increased when the output current was increased.The patient reported that dizziness was present when standing and subsides when she lays/sits down.It was stated that the dizziness is constant when she stands.The physician reported that the patient has had dizziness in the past due to previously prescribed aeds prior to implant.However, no medications have been changed since vns implantation.The physician lowered the output current from 1.25 ma to 0.75 ma and the adverse event did not resolve.The physician disabled the vns in order to determine if the issue resolved.Follow up with the physician's office revealed that they had disabled the "scheduled doses" and that the patient could only manually stimulate, which was confirmed to mean that only magnet mode was programmed on.The physician stated that it was believed that the main component of the dizziness was due to anxiety.Diagnostics were within normal limits.It was later reported by the patient¿s daughter that the patient was referred for vns explant surgery in (b)(6) 2019.It was stated that the vns was ¿triggering epilepsy for the patient¿ and they wanted to move up the surgery date.The daughter later reported that the patient was experiencing dizziness, ambulation difficulties (disbalance), headaches, and a lack of energy.No relevant surgery is known to have occurred to date.No additional relevant information has been received to date.

Event Description

It was later reported that the patient was experiencing left arm and leg pain, and high blood pressure.It was stated that the patient only seemed to have the symptoms when the vns was programmed on.The physician disabled the device.It was stated that the patient reported that the pain was feeling better after disablement.Follow up with the physician's office was related to vns stimulation as it did not seem to occur after disablement.The physician was unsure if the increased blood pressure was related to vns and stated that maybe there is some cardiac or peripheral vasculature stimulation.It was stated that the device disablement was for the patient's comfort.Further follow up on the initial reported events revealed that the physician could not provide any information regarding the reported seizures as the patient did not mention them to the physician.While the physician was unsure how the dizziness, disbalance, headaches, and lack of energy could relate to vns, he stated that it seems to point to vns stimulation.The physician recommended against the patient having further surgery.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8927290
• MDR Text Key: 155409599
• Report Number: 1644487-2019-01643
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2020
• Device Model Number: 1000
• Device Lot Number: 5614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2018
• 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; Required Intervention
• Patient Age: 66 YR