how long before more former employees start to bring suit against NuVasive for being forced into unethical practices of placing leads and patient contact? the company line is a 'lay no hands' policy, but the understood message is that if no one is looking get the job done. new reps are discouraged by management, but senior reps say otherwise. . . even the regional managers are placing leads when covering cases. just hold the wheels steady a little bit longer . . .
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1918239 "the neurovision jjb system may not be effective, and is not intended for use, when muscle relaxants or epidural blocks have been used for, or in conjunction with, anesthesia. " Uhhhh...aren't patients under anesthesia during surgery when the Neurovision is used??? Holy crap batman......Anyone interpret that MAUDE event differently?????
Are you saying company salesreps are placing nerve monitoring leads on patients and not medical personnel prior to surgery????? ISn't that illegal? Wouldn't that lead to Surgeons losing their medical licenses? They end up liable in the end. Maybe that's why the company doesn't care if salesreps place the leads on patients?? They can't be held liable?? No medical license to lose....smart....
So it seems the times have not changed...How is it that a rep can place the leads on a patient????Now they claim to be trained to place leads? WHen did it become ok to touch a patient period. Anyone????
“”the neurovision jjb system may not be effective, and is not intended for use, when muscle relaxants or epidural blocks have been used for, or in conjunction with, anesthesia”” http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1918239 The Nerve Monitoring System isn't perfect anyways.
....Why did all the Reports disappear from the FDA Maude website for Nuvasive? ha ha ha ha!! $$$$$$ Take a look.... www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
Your lack of education on this topic is apparent by your posts. Please educate yourself prior to making such statements, and certainly before speaking to a HCP on the topic. Assuming you are referring to monitoring EMG, the method of recording data is the same for any neuromonitoring system: myotomes firing from associated nerve depolarization. If muscles are paralyzed (due to paralytics or muscle relaxants), EMG WILL BE FALSELY NEGATIVE... PERIOD. It is common practice to anesthetize the patient in conjunction with either short acting or no paralytics so EMG monitoring will provide accurate data. I have not seen a NuVasive rep place hands on a patient... ever. The electrodes are individually labeled and the rep can help guide a HCP in placement (per the labeling and education card in every kit). Consider this a favor. I'm saving you the embarrassment of making false, inflammatory statements and revealing you lack of education.
Oh please.... who crawls under the sterile field and replaces a lead when it falls off during surgery??? Lets vote. A. The surgeon B. The PA C. The Circ Nurse D. The Nuva rep ... oh yeah - and w/o touching the patient. LMAO
Some Nuvasive news here: http://www.miller-mccune.com/business-economics/are-professors-picking-the-publics-pockets-35531/ UC San Diego was robbed of Technology/money.... Nuvasive made money on...along with Dr. William Taylor. www.signonsandiego.com/news/2011/jan/19/ucsd-surgeon-fined-over-research-payments/ Something big this way cometh....why did FDA Maude make all those MAUDE reports disappear??.....or are they going to cover it all up so more money can be made?..Gotta have jobs...even if it kills.
FDA Maude did have only 3 reports showing for Nuvasive. The rest are all back up on the Maude site now. Odd they removed them for a little while. Hmmm.....What's somebody at the FDA trying to hide?
I had a XLIF surgery in 2009. The operation lasted from lasted 3.5 hrs (starting at 8:26 am and ending at 11:57 am), however, the NeuroVision JJB monitor was only utilized for 2 hours and 35 minutes. In addition, the NeuroVision JJB Summary Test Report shows “Neuromuscular Junction: Number of nerves tested” as blank or zero. The NuVasive Rep. was Holly Rinaldi. Anyone have any thoughts or helpful info. There was one surgeon in the room, one intern, 2 stryker reps, 1 NuVasive rep. Who was running the JJB machine?
^^^^^the surgeon runs the machine, this is a different from other neuro monitors. as far as testing time, you wouldn't run the machine except for actually surgery time (incision time, not room time) and may turn off while closing, so the time doesn't matter. Better question is who put the leads on? were they surface or needle electrodes? 7 years out of surgery....how you doing?
What I do not understand is...United States ex .rel Kevin Ryan vs Nuvasive ruled the XLIF was not a spine fusion...the Nuvasive bone growth stuff crammed in the middle of the Coroent XL was illegal to use there......Federal Government and States got their money back for paying for Spine Fusions...no fusions done... Investors just won a Federal Class Action...over the above court case...AND what came out of it...Doctors were getting paid kickbacks by Nuvasive to do the illegal surgery.....Investors won money from Nuvasive.... But....what about the patients? There has been no Federal Class Action for the patients who never got a spine fusion.
Of interest to note...A certain medical college project in California doing the XLIF in Cali...and whom did the XLIF surgeries starting in 2008 at the San Francisco Veterans Affairs...the “surgeon” is now off in Pittsburgh preaching Psychology at a school..and the NUVA rep fled the country to start up a medial device selling business in Australia. Poor poor Veterans... The dogs they practiced on first were treated more humanely. 8 hours to do a XLIF surgery....yes... Since Obama told Nuvasive to track who they did XLIF surgeries on...how many are now dead? Nuva Rep Nate “The Rock” Quarry wasn’t stupid...flew out of the country to get his XLIF removed and fixed correctly. Is he still getting paid by Nuva after that little secret?
The 2 posters above have no idea what they are talking about....I do not even work for Nuvasive, but XLIF is (Extreme lateral interbody fusion) a fusion, just like PLIF, TLIF. All interbody fusion techniques (all widely accepted). The "stuff" they put inside may be "off label" (I do not know the labeling of their products) but it is not "illegal". Learn what you are talking about. Many medical devices, in all surgeries (not just spine) are used "off label". The part about Veterans being treated poorly also has nothing to do with Nuvasive. The surgeon at the hospital or VA determine the type of surgery and approach/technique. Almost every company has a lateral approach and implants now too, not just Nuvasive. Mic drop.......moron.
