InterStim II
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 SeriousCurrent labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.
💡 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.
9/27/2017 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousA software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .
💡 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.
10/7/2010 · 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.
Regulatory Info
No 510(k) clearance data available for this device.
Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.
Category
Sacral Nerve Stimulators
Body Region
Pelvis
View Manufacturer MR Safety Documentation
Official Medtronic, Inc. guidelines
Post-MRI Notes
Device should be interrogated after MRI to verify settings.
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.