Vanta Implantable Neurostimulator May Become Unresponsive During Cardioversion
Cardioversion procedures can damage electronics in Vanta implantable neurostimulators, making them unresponsive. Medtronic has received two complaints resulting in device removal surgeries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall with documented device malfunction confirmed in two patients requiring surgical explant procedures. Source does not explicitly report hospitalizations or injuries, preventing a higher severity classification.
Plain-English summary
The Vanta with AdaptiveStim Implantable Neurostimulator (Model 977006), manufactured by Medtronic Neuromodulation, is used for spinal cord stimulation. Approximately 3,791 devices have been distributed worldwide.
A cardioversion procedure—an electrical treatment used to restore normal heart rhythm—can damage the device's electronics, causing it to become unresponsive and non-functional.
As of April 19, 2023, Medtronic has received two complaints about this issue from patients with implanted Vanta devices. Both cases resulted in explant procedures, in which the device was surgically removed. Patients who have received a Vanta implant should contact their healthcare provider if they require a cardioversion procedure or have concerns about their device.
The recalled product
- Product
- Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 3,791
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00763000411923
- Serial/Lot Numbers: NMS504094H
- NMS504258H
- NMS504861H
- NMS503154H
- NMS503612H
- NMS503371H
- NMS503748H
- NMS504643H
- NMS504701H
- NMS504404H
- NMS504802H
- NMS504344H
- NMS504771H
- NMS504778H
- NMS504650H
- NMS501450H
- NMS504544H
- NMS501538H
- NMS503203H
Distribution
Distribution scope not specified by the agency.
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