MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Anxiety (2328); Cognitive Changes (2551); No Code Available (3191)

Event Date 11/02/2018

Event Type  Injury  

Event Description

It was reported that the patient was experiencing akathisia.The report indicated that the akathisia was "probably related" to vns implant and vns stimulation.The patient had their device disabled due to the akathisia.The patient still experienced akathisia when the device was disabled, however, the akathisia worsened when generator settings were altered to mitigate the side effect.Akathisia was also described as "restless legs." it was also stated that the patient continued to experience the akathisia despite additional pharmacotherapy.It was additionally reported that the patient's akathisia increased the patient's risk of self-harm and/or suicide.No further relevant information has been received to date.

Event Description

It was reported that the patient suffered from restless leg syndrome, which was exacerbated by several medications in the past, but had been remitted to tolerable levels.It was reported that when the patient was treated with the lowest possible current and frequency of vns stimulation, the patient developed intolerable restlessness which fully normalized after several hours.The restlessness was associated with suicidal thoughts, which the patient could reportedly control.The reported relationship between the physiological effects of stimulation was "questionable" per the physician, as the patient developed restlessness on an occasion when the patient believed the stimulation to be on, but the stimulation was indeed turned off.It was reported that the patient was being slowly titrated back on the vns and that the patient had worsening of restless leg syndrome with almost every other medication that has been attempted.It was reported that the patient's previous antidepressant treatments aggravated the restless leg syndrome.No further relevant information has been received to date.

Event Description

It was reported that the patient's adverse event resolved.No further relevant information has been received to date.

Manufacturer Narrative

Serial #, lot #, expiration date corrected data: initial report inadvertently listed incorrect generator.Device manufacture date corrected data: initial report inadvertently listed incorrect generator manufacturing date.

• Brand Name: PULSE GEN MODEL 103
• 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: 8153683
• MDR Text Key: 130074119
• Report Number: 1644487-2018-02271
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2020

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 Expiration Date: 10/21/2018
• Device Model Number: 103
• Device Lot Number: 5088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 05/21/2019; 11/19/2019; 03/18/2020
• Supplement Dates FDA Received: 06/14/2019; 11/19/2019; 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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: 29 YR