Recall Z-0860-2021— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2020-11-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.. Reason: A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-11-12
- Firm location
- Minneapolis, MN, United States
Product description
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
Reason for recall
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.