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Open, Classified

Model A710 Intellis Clinician Programmer Application, version 2.0.97

FDA Recall Z-0780-2024 · Posted 2024-01-22

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeLGW
Date Initiated2023-12-19
Product Quantity1 tablet

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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Germany

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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