Medtronic Kinetra
Medtronic, Inc.
What this means for you
MR Unsafe — do not bring into the MRI scanner room. This device cannot safely be in the MRI suite. If a scan is essential, your physician will discuss alternatives.
For information only — your MRI team makes the final decision before any scan. They check every patient, every time.
FDA Recall Alert
Class I — Most SeriousSoftware issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
6/24/2007 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousCessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
5/2/2012 · View on FDA.gov
⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.
Category
Neuro
Body Region
Deep Brain Stimulators
MRI Conditions
Legacy device. NOT MRI conditional.
Clinical Warnings
WARNING: Legacy DBS. MRI is CONTRAINDICATED.
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.