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Deep brain stimulation clinician and patient programmer applications
Official notice
5 Jun 2024
Last checked
5 Jun 2024
An official Health Canada notice concerns Deep brain stimulation clinician and patient programmer applications. 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 Published 2024-06-05.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75626
Official notice
2024-06-05
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
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Company & contacts
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Brand: Medtronic, Deep Brain Stimulation Clinician And Patient Programmer Applications.
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Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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