Official recall record

Deep Brain Stimulation Clinician and Patient Programmer Applications

What the authority reported

Manufacturer notification to inform customers of an issue related to the Magnetic Resonance Imaging (MRI) eligibility status displayed in certain versions of the Deep Brain Stimulation (DBS) clinician programmer and DBS patient programmer applications. Patients implanted with a pocket adaptor are limited to "head only" MRI eligibility. With this issue, the clinician and patient programmers may incorrectly display MRI eligibility as "full body" scan eligible. This issue has the potential to result in exposure of the patient to an incorrect MRI (e.g., "full body" instead of "head only" scan eligibility), which could result in heating at the lead electrode(s) and potential tissue damage. Excessive heating can result in serious or permanent injury including coma, paralysis, and death. There has been one (1) reported event of this issue, which was identified during initial programming. As of April 2024, there have been no reported patient harms for this issue. Recall Start Date: May 15, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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