anonymous
Guest
anonymous
Guest
Let me help you my technically-challenged friend.I keep looking but all I see are NVRO -kindly show me where Algovitas are being explanted.
If you want to read them all you do is go to
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
Click on "ALL YEARS" and in the search bar type "Nevro and explant" or "Algovita and explant."
MAUDE entries for Nevro and Explant totals 213 but at least some of those entries say "not explanted" so more like 167.
MAUDE entries with Algovita and Explant total 13. There aren't many entries in MAUDE for Algovita. Takes less than ten minutes to read them all even if you're one of the mouth-breathing, knuckle-dragging, entitled sales reps I compete against.
No, they tell you to return the devices. Even in their labeling. Physician manual says "All explanted IPGs should be returned to Nevro Corp." In case you don't have your own copy in your competitive literature library, here's the version from the FDA submission.Also, does NVRO tell you not to return explanted devices?
https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022d.pdf
They tell you to return them to analyze device failures - in part to sort out legitimate issues from non-issues. Also to say anything else would be even dumber than your post.Why is that?