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Recall Observatory FDA recall evidence

Device product

Model A710 Intellis Clinician Programmer Application, version 2.0.97

Z-0780-2024

December 19, 2023

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 93714
Status
Ongoing
Classification
Class II
Quantity
1 tablet
Official record key
device-enforcement:Z-0780-2024

Official wording

Reason: 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.

Code information: UDI/DI 00763000520076, S/N: NPL1000519

Distribution pattern: Germany

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.