The letter communicated mitigations to reduce the risk of damage to the Model 977006 Vanta from a cardioversion procedure. It was dated June 2023.
Medtronic said a cardioversion procedure may damage the electronics in the Vanta INS device. This could render the INS unresponsive and non-functional. As of April 19, 2023, Medtronic received a total of two complaints concerning this issue, according to the notice. Both complaints, which came from patients implanted with Vanta INS, resulted in explant procedures.
The company said it identified programming mitigations that reduce the risk of damage associated with this issue. In the event of damage to the device, Medtronic said surgical INS replacement is required to restore stimulation therapy. Cessation of therapy likely causes a return of pain symptoms.
Medtronic said users can minimize the potential for electrical damage to Vanta INS by temporarily reprogramming it. Users can find recommendations for reprogramming for cardioversion procedures in the IFP manual. Medtronic updated the IFP manual and applicable labeling to add specific recommended settings and considerations for these procedures.
The company also updated its patient therapy guide. This update instructed patients to inform clinicians of any upcoming cardioversion procedures. Medtronic said this helps determine proper programming for the Vanta INS as indicated in the IFP.
About the Medtronic Vanta implantable neurostimulator
FDA approved the Vanta recharge-free implantable neurostimulator (INS) in June 2021. Medtronic says Vanta has a device life of up to 11 years — more than twice the device life of competitive primary cell devices.
Vanta uses Medtronic’s proprietary AdaptiveStim technology. It adapts to the patient’s movement or body position through a built-in accelerometer. The platform can automatically adjust stimulation to maintain each patient’s optimal dose.
Vanta features a 10% increase in longevity compared to the previous generation PrimeAdvanced. Its design marks a 20% decrease in size compared to PrimeAdvanced. Medtronic says it offers more rounded, ergonomic contouring for enhanced comfort.
The platform can access Medtronic’s proprietary Snapshot data insights solution. This enables clinicians to access objective reports of patient activity levels.
