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Restore™ Clinician Programmer Application Recall Due to Medtronic is initiati...

# Major Recall Alert: Medtronic’s Restore™ Clinician Programmer Application Faces Potential Software Issue

Medtronic has announced a significant **medical device recall** related to its **Restore™ Clinician Programmer Application (Model A71100)**, which is used to program the Restore family of Spinal Cord Stimulation implantable neurostimulators (INS). This recall is due to a **software issue** that may prevent users from clearing a "device reset" message. This issue, in rare cases, could lead to the inability to resume therapy for patients, possibly resulting in the recurrence of underlying pain symptoms. If unresolved, this might necessitate invasive surgical intervention to replace the neurostimulator.

This blog post dives deeper into why this recall deserves your attention, who it affects, and what steps you should take to ensure your safety.

## Why This Recall is Important

This recall carries serious implications for those who rely on **Spinal Cord Stimulation (SCS)** devices to manage chronic pain. Here’s what’s at stake:

- The **Restore™ Clinician Programmer Application** is crucial for the programming and troubleshooting of SCS neurostimulators. When the device encounters a reset message, the app typically clears it during a programming session.
- However, Medtronic has identified a software glitch in the Model A71100 CP App that may prevent users from resolving the reset message under certain circumstances.
- The problem primarily occurs when the neurostimulator’s battery becomes overdischarged. If unresolved, patients may lose access to their pain management therapy, potentially requiring **surgical replacement of the device**.
- While these cases are rare, the potential consequences are severe enough to prompt this proactive recall.

### Details of the Recall

**Here’s what you need to know about the Medtronic Restore™ Clinician Programmer Application recall:**

- **Product Affected**: Model A71100 Restore™ Clinician Programmer Application (CP App)
- **Recall Reason**: Potential software issue preventing the clearing of a "device reset" message.
- **Impacted Features**: The app, which supports Spinal Cord Stimulation implantable neurostimulators (INS), may fail to resume therapy in rare cases.
- **Potential Outcome**: Inability to resume therapy, recurrence of pain symptoms, and possible requirement for surgical replacement of the device.
- **Date Announced**: Referenced in official Medtronic documentation.
- **Safety Advisory**: Patients and healthcare providers are encouraged to monitor and resolve device reset issues promptly by contacting Medtronic.

For official recall information, visit: [Medtronic Restore™ Clinician Programmer Application Recall Alert](https://recalls-rappels.canada.ca/en/alert-recall/medtronic-restoretm-clinician-programmer-application).

### What You Should Do

Medtronic has already started notifying consignees about the issue. Here’s how you can stay prepared and act if you’re affected:

- **Patients**:
- If you use a Medtronic SCS neurostimulator, reach out to your healthcare provider to check if the device reset issue impacts your therapy.
- Report any problems with your neurostimulator immediately. Do not ignore recurring or persistent issues.
- Discuss backup pain management solutions with your medical team in case therapy is interrupted.

- **Clinicians**:
- Ensure you update your programming tools with the latest guidance from Medtronic.
- Reach out to Medtronic or review the recommendations outlined in their recall notification for troubleshooting strategies.
- Monitor patient devices likely to encounter this issue, particularly neurostimulators with overdischarged batteries.

### Stay Safe – Get Instant Recall Alerts

Medtronic’s proactive recall highlights the importance of staying informed about potential device malfunctions, especially for medical devices essential to pain management. To safeguard your health and ensure uninterrupted therapy:

- Subscribe to **local or regional recall alerts** for healthcare devices. They provide timely notifications of issues like the one discussed here.
- Stay updated through Medtronic’s official website or by contacting their customer support for the latest software and safety updates.
- Regularly schedule check-ins with your healthcare provider to review your device's performance.

For more information, visit the official recall notification page here: [Medtronic Restore™ Clinician Programmer Application Recall](https://recalls-rappels.canada.ca/en/alert-recall/medtronic-restoretm-clinician-programmer-application).

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**CTA:** Are you up-to-date with the latest Medtronic updates? Ensure your programming tools for the Restore™ Clinician Programmer Application are optimized. Contact Medtronic and download updated solutions for your devices today!

By staying proactive, both patients and clinicians can mitigate risks and maintain effective pain management therapies without disruption.

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