That is because Medtronic invested and successfully navigated through the consent decree* deliverables to ensure patients continue to receive the therapy. Medtronic delivered on all FDA expectations in regards to a quality work plan and product enhancements, which enabled us to exit the certification process.
* Consent decree is a formal agreement with the FDA to address its expectations in regards to: (a) SynchroMed™ II and; (b) overall neuromodulation quality system. It gives the FDA greater oversight of our existing quality improvement efforts and provides a path forward with steps and timelines (three pillars, quality work plan, pump remediation plan and distribution controls/notification of associated persons).
Using Medtronic’s scale and real-life data with a registry of almost 7,500 patients, and returned product analysis, we have identified three main causes for the majority of motor stalls. This is why we have recently improved SynchroMed™ II with four durable design enhancements that aim to improve reliability and bring motor stalls to a minimum.
1 Based on all pumps returned and analyzed for motorstalls
2 Medtronic data on file. The implementation of these three design changes
does not imply an equivalent percent reduction in motor stall
BETTER QUALITY PROCESSES
Medtronic has worked with best-in-class external experts in quality, to develop robust business processes to ensure optimum quality. This aims to consistently meet our customers and patients’ requirements and enhance their satisfaction. Our new quality processes have successfully passed third party and FDA audits in 2017.
We are fully focused on investing into innovations that will positively impact your practice and improve your patients’ lives. Over the upcoming months you will be exposed to a range of new product innovations and level 1 clinical evidence, so stay tuned!
Durable Design enhancements aim to reduce motor stalls, and therefore reduce the risk of over/ underdose and revision surgeries.
Through less revision and replacement surgeries, with durable design enhancements and improved quality systems that aim to reduce motor stalls.
Through less revision surgeries with durable design enhancements.