Deep Brain Stimulation Clinician and Patient Programmer Applications
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Pocket Adaptor Kit For Deep Brain Stimulation | More than 10 numbers, contact manufacturer. | 64001 64002 |
| Activa SC - Neurostimulator | More than 10 numbers, contact manufacturer. | 37603 37602 |
| Activa Clinician Programmer Application For Deep Brain Stimulation | More than 10 numbers, contact manufacturer. | A610 |
| Patient Programming Application For Deep Brain Stimulation | More than 10 numbers, contact manufacturer. | A620 |
| Percept PC Brainsense Deep Brain Stimulation Implantable Neurostimulator | More than 10 numbers, contact manufacturer. | B35200 |
Issue
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
Additional information
Details
Medtronic Inc.
710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
Get notified
Receive notifications for new and updated recalls and alerts by category.