Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation

FDA device recall Z-2036-2023 · posted 2023-06-29 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.

Action taken

Medtronic issued an Urgent Medical Device Correction notice to impacted physicians on 06/06/2023 by letter. The notice explained the problem and the hazard associated with the use of the device during cardioversion procedures. It also provided the following information: Required Actions: " Please communicate to your patients the above Instruction for Prescribers (IFP) and Patient Therapy Guide (PTG) updates regarding programming considerations for cardioversion procedures with patients implanted with Vanta INS devices. " If a patient will be undergoing a cardioversion procedure (e.g., nonemergent scenario) refer to the recommended neurostimulator settings and programming considerations in the Information for Prescribers (IFP) manual which include not turning off your patient s Vanta INS device and reprogramming the settings. " After a cardioversion procedure, confirm that the neurostimulator is functioning and programmed as intended. Contact Medtronic if you have any questions. " For patients who are considering a new or replacement implant, and who have concomitant conditions such that they may require future cardioversion, please talk to these patients about the relative benefits and risks associated with proceeding with a Vanta INS device. " Share this notice with all those who need to be aware of this issue within your organization or to any organization where the potentially affected devices have been transferred and maintain a copy of this notice in your records. " Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. Notification will be to the patient level.

Root cause

Device Design

Status

Open, Classified

Product code

LGW

Quantity affected

3791 devices

Distribution

Worldwide distribution.

Date initiated

2023-06-06

Date posted

2023-06-29

Location

Minneapolis, MN