Abbott issued an urgent medical device correction in July 2023 after receiving reports that some

devices would not turn back on after exiting MRI mode.

The recall warning letters were not sent to patients with Abbott DRG Proclaim implants until October 2023.

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The FDA has identified this as a Class I recall, the most serious type of recall.

Use of these devices may cause serious injuries or death.

ABBOTT launched sales of DRG Proclaim in Europe in 2017.

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Opening paragraphs of letter:

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October 2023

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Dear Patient,

 

This letter is to notify you about important information regarding your Proclaim™ Neurostimulation System, should your physician determine that you need a future Magnetic Resonance Imaging (MRI) scan. Your patient controller includes a feature called MRI mode which allows you and your device to be safely scanned. 

The scope of this correction is related to the inability to exit MRI mode in specific situations. If additional troubleshooting steps are unsuccessful, the implanted device would be unable to exit MRI mode and resume normal operation. This would require device replacement surgery to restore therapy. If you are using MRI mode, there are steps you should take to avoid this issue. 

 

Copy of complete two-page letter attached at images below:

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Pudendal Neuralgia Alliance

contact@pudendalneuralgiaalliance.org

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