Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Reported: July 5, 2023 Initiated: June 6, 2023 #Z-2036-2023
Product Description
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 3791 devices
- Distribution
- Worldwide distribution.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation. Recalled by Medtronic Neuromodulation. Units affected: 3791 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2023. Severity: Moderate. Recall number: Z-2036-2023.
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