Vanta (neurostimulator)

2023: Defibrillator discharge disables Medtronic neuroimplants

In mid-June 2023, information appeared that Medtronic warned medical professionals in Europe about the risk of damage to the implantable neurostimulator Vanta, namely model 977006, as a result of cardioversion.

During cardioversion, health care providers use a defibrillator to shock the patient's heart back into a normal rhythm. It is commonly used for atrial fibrillation and flutter, but also helps with other rapid or irregular heart rhythms. Although this can save your life, if the patient has ventricular arrhythmia, then according to Medtronic, the procedure can damage the electronics of the Vanta device, as a result of which it will stop responding and will not function.

Vanta (neurostimulator)

As of April 19, 2023, Medtronic received two complaints about the issue from patients who had a Vanta device implanted, and in both cases the implantable device had to be removed, the company noted in a June letter to health care professionals.

Medtronic reported that the company has identified software measures that reduce the risk of damage. If the device is damaged, surgical replacement of the neuroimplant is required to restore the stimulating therapy. The potential for electrical damage to the Vanta ventilator can be minimized by temporarily reprogramming the patient's device to perform cardioversion procedures, as recommended in the device's operating manual.

Medtronic updated the guidance and appropriate labeling, adding specific recommended neurostimulator settings and programming considerations for cardioversion procedures. According to Medtronic engineers, the development company has also updated the patient care guide to let patients know they need to tell the doctor about upcoming cardioversion procedures so that Vanta can be properly programmed.

Necessary actions for healthcare professionals managing patients with implanted Vanta devices undergoing cardioversion:

• 1. Inform patients of updates regarding programming of cardioversion procedures for patients implanted with Vanta devices;

• 2. If the patient has a cardioversion procedure, check the recommended neurostimulator settings and programming considerations in the manual, which include not turning off the patient's Vanta device and reprogramming the settings;

• 3. After the cardioversion procedure, it is necessary to make sure that the neurostimulator functions and is programmed as necessary;

• 4. With patients who are considering a new or replacement implant and have comorbidities in which cardioversion may be required in the future, the relative benefits and risks associated with using the Vanta device should be discussed with the patient;

• 5. Distribute urgent field notification to anyone who needs to be aware of this issue in your organization or to any organization where the potentially affected 977006 devices have been transferred and keep a copy of the notification in your documentation.^[1]

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