RecallDepth

Model A710 Intellis Clinician Programmer Application, version 2.0.97

Company
Medtronic Neuromodulation
Recall Initiated
December 19, 2023
Posted
January 22, 2024
Recall Number
Z-0780-2024
Quantity
1 tablet
Firm Location
Minneapolis, MN

Reason for Recall

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.

Distribution

Germany

Lot / Code Info

UDI/DI 00763000520076, S/N: NPL1000519

Root Cause

Under Investigation by firm

Action Taken

OUS communication to a single German consignee will be initiated via regionally approved methods beginning 19-Dec-2023. A field service technician will go to the site and reset the INS to resolve the issue.

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