medical Class II Updated 2024-01-31

Medtronic Neuromodulation recalls Model A710 Intellis Clinician Programmer Application, versio

Recalled Product

Model A710 Intellis Clinician Programmer Application, version 2.0.97

Hazard / Issue

Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.

Issued by

FDA

Distribution: Germany
Lot/Code Info: UDI/DI 00763000520076, S/N: NPL1000519
View official government recall

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