Nevro Senza Battery Issues and Explants

For your company to be so arrogant about Senza is asinine. There are multiple reports from my customers that patients are having their HF10's removed due to the battery being so big and having to be recharged everyday. The battery is also hard to place and some patients end up having the battery cut through their skin!

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My situation is different, their paddle started malfunctioning and losing electrodes after five months. Their answer was that that’s normal which it isn’t, and they still have other electrodes to use, just not the ones that were helping. That’s when it went south. They try different people in the field running different programs and they couldn’t dial the stimulator in because it continued to lose electrodes ( 6 in all in less than in year) Then the tech purposely left me with one working program and 1 that I was told not to use and one that shocked me. I was to hear back from Nevro within 2 weeks for a fix. That return call NEVER happened. That was the last I heard from Nevro. Move ahead 10 months, and the I receive a survey from them, not a phone call, a survey. All the surveys that they use in their percentages that they feed possible patients to try the stim are purposely biased towards Not being able to say anything negative about the stimulator. I called and requested a manager to call back because the “” care representative” that called me back could care less. That manager took two weeks to call, and his name was Jay Meeth. After over an hour and 20 minutes with him on the phone he never took responsibility as a person or a company. As a Manager, and everyone below him that was suppose to be working on a unit that was mechanically failing, did NOTHING. I asked him what he thought about that, and his only answer was he will talk to his team. No apologies about Nevro’s gross negligence in the handling of my case, or the incompetence that had been shown by Nevro’s salespeople in the field, and then shown by Mr. Meeth himself, by not being able to answer yes or no questions on a Nevro recorded line. His only answer was when I have it taken out, I should send it back so they can figure out what happened and send the results to the FDA. What a joke, a company whose warranty specifically states that they would replace a faulty unit if it were not work correctly. Mr. Meeth made it very clear that he did not care about that, and also that the company had no care in making the situation right, being Nevro was totally at fault by not taking care of their equipment per the warranty. He would much rather me keep it so they don’t have to report anything to the FDA, and subsequently to any patients about another failure that happened with their device. Never was I told before the trial that the stimulator paddle could possibly fail. My neurosurgeon says it should not have and they should’ve replaced it when they knew it was malfunctioning. They never contacted my doctors about it, they only told them that they were reworking the programs to dial it in. People, please do your homework before even thinking about putting a Nevro stimulator in. The people you deal with are salesman, most of whom do not even know how to operate a computer and reprogram the stimulator. They will feed you a line that they’ve got this great percentage of people that the the stimulator works, but fail to tell you that those numbers do not include medical device failures. Management DOES NOT CARE. Cases like mine where the stimulator was working and then stopped working because of their device failure drop to the bottom of their care list because they don’t want to incur the expense of putting a new paddle in. I understand business is about the bottom line, but it should not come at the cost of a patient when their device fails and their answer and response to that failure is to do nothing and not contact a patient. Currently, I am waiting for a Mr. Paul Mandina to call me back and tell me what he thinks about the ethical and moral failures his company has made in this process, and why his company does not care about the upkeep in their equipment. As like every return call from Nevro,

Have you heard back from Nevro? I have a similar situation.

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I am very sorry to hear of your situation. My experience has just been the opposite. My Nevro reps always make themselves available and the customer service has been great. Nevro is the only SCS that I would recommend. I hope you feel better

Nevro is the only SCS you would recommend? How many have you tried

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I am very sorry to hear of your situation. My experience has just been the opposite. My Nevro reps always make themselves available and the customer service has been great. Nevro is the only SCS that I would recommend. I hope you feel better

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My situation is different, their paddle started malfunctioning and losing electrodes after five months. Their answer was that that’s normal which it isn’t, and they still have other electrodes to use, just not the ones that were helping. That’s when it went south. They try different people in the field running different programs and they couldn’t dial the stimulator in because it continued to lose electrodes ( 6 in all in less than in year) Then the tech purposely left me with one working program and 1 that I was told not to use and one that shocked me. I was to hear back from Nevro within 2 weeks for a fix. That return call NEVER happened. That was the last I heard from Nevro. Move ahead 10 months, and the I receive a survey from them, not a phone call, a survey. All the surveys that they use in their percentages that they feed possible patients to try the stim are purposely biased towards Not being able to say anything negative about the stimulator. I called and requested a manager to call back because the “” care representative” that called me back could care less. That manager took two weeks to call, and his name was Jay Meeth. After over an hour and 20 minutes with him on the phone he never took responsibility as a person or a company. As a Manager, and everyone below him that was suppose to be working on a unit that was mechanically failing, did NOTHING. I asked him what he thought about that, and his only answer was he will talk to his team. No apologies about Nevro’s gross negligence in the handling of my case, or the incompetence that had been shown by Nevro’s salespeople in the field, and then shown by Mr. Meeth himself, by not being able to answer yes or no questions on a Nevro recorded line. His only answer was when I have it taken out, I should send it back so they can figure out what happened and send the results to the FDA. What a joke, a company whose warranty specifically states that they would replace a faulty unit if it were not work correctly. Mr. Meeth made it very clear that he did not care about that, and also that the company had no care in making the situation right, being Nevro was totally at fault by not taking care of their equipment per the warranty. He would much rather me keep it so they don’t have to report anything to the FDA, and subsequently to any patients about another failure that happened with their device. Never was I told before the trial that the stimulator paddle could possibly fail. My neurosurgeon says it should not have and they should’ve replaced it when they knew it was malfunctioning. They never contacted my doctors about it, they only told them that they were reworking the programs to dial it in. People, please do your homework before even thinking about putting a Nevro stimulator in. The people you deal with are salesman, most of whom do not even know how to operate a computer and reprogram the stimulator. They will feed you a line that they’ve got this great percentage of people that the the stimulator works, but fail to tell you that those numbers do not include medical device failures. Management DOES NOT CARE. Cases like mine where the stimulator was working and then stopped working because of their device failure drop to the bottom of their care list because they don’t want to incur the expense of putting a new paddle in. I understand business is about the bottom line, but it should not come at the cost of a patient when their device fails and their answer and response to that failure is to do nothing and not contact a patient. Currently, I am waiting for a Mr. Paul Mandina to call me back and tell me what he thinks about the ethical and moral failures his company has made in this process, and why his company does not care about the upkeep in their equipment. As like every return call from Nevro,

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no relief after a year hundreds of programs. Just turned it off. Will have it remove

Hate my Nevro. Battery huge and lied to me about charging and size. Now burns and I want it out. Terrible rep. Misrepresentation from the start. Check out more than one stimulator before choosing. Read patient manual online

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An analyst asked a question about a higher rate of explants with HF10 (according to chatter) and Rami alluded to Nevro having less than half of the amount compared to competitive systems.

Quote from Rami-

"So I think naturally it’s not a logical surprise that our explant rates are also less than half of alternatives as well. I think we have – obviously, we’ve had this data and we want to make sure that the combination of both the real world outcomes and the RCT data together provide a compelling picture, which obviously you picked up on."

"I think the best reference, if you’re asking specifically about how it compares, the only real reference you can compare to is in an RCT like ours or again we have less than half of the explant rate of traditional SCS, I think comparing outside of controlled stuff like that is more difficult. In other words, I can’t comment on what the competitive real world explant rates are. All I can do is reference various highly controlled [indiscernible] RCT in the history of this space and I think that’s fairly."

*Cough* *cough* Bullshit *cough*

The MAUDE database would disagree with his statement.

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An analyst asked a question about a higher rate of explants with HF10 (according to chatter) and Rami alluded to Nevro having less than half of the amount compared to competitive systems.

Quote from Rami-

"So I think naturally it’s not a logical surprise that our explant rates are also less than half of alternatives as well. I think we have – obviously, we’ve had this data and we want to make sure that the combination of both the real world outcomes and the RCT data together provide a compelling picture, which obviously you picked up on."

"I think the best reference, if you’re asking specifically about how it compares, the only real reference you can compare to is in an RCT like ours or again we have less than half of the explant rate of traditional SCS, I think comparing outside of controlled stuff like that is more difficult. In other words, I can’t comment on what the competitive real world explant rates are. All I can do is reference various highly controlled [indiscernible] RCT in the history of this space and I think that’s fairly."

*Cough* *cough* Bullshit *cough*

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I only have to charge my Nevro HF10 every other day. I can do it while driving, watching tv, sleeping. No big deal.

Charging while sleeping is a good way to get burned. Per Nevro's patient manual, 11052 Rev D, "CAUTION: Do not charge your IPG while you are drowsy, sleeping, or sedated, as this may result in a burn. If you feel warmth or discomfort around the Charging Coil, discontinue the charging process and contact your doctor."

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I only have to charge my Nevro HF10 every other day. I can do it while driving, watching tv, sleeping. No big deal.

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Yet Rami and the rest of sales management think 30% growth is achievable. I give ya some help. it's not. The management failures of Rami and his team should be written about at Harvard Business School.

If you can’t achieve 30% growth quarter over quarter, in perpetuity, then go work for someone else. Nevro is for winners, not whiners!

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1... absurd quota's are *****!

1, not a warm and fuzzy place to build a career in sales!

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Nearly equivalent? Is that an oxymoron? As in the battery is "kind of the same size but bigger"? I'll give you tingling by clearly NOT "better pain relief", and the Docs "headache factor" dwarfs the competitors which is one reason why they are losing share. If the outcomes were really (as in "real world") "superior", they would be gaining share. BTW-"non paresthesia" is no longer unique to Nevro , she with rechargeable.

Yet Rami and the rest of sales management think 30% growth is achievable. I give ya some help. it's not. The management failures of Rami and his team should be written about at Harvard Business School.

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If it makes you feel any better, the Nevro rep probably lied to you because he or she was afraid for their job and needed the implant revenue...and probably got fired anyway.

1... absurd quota's are *****!

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Your email address will never be used for any other reason and will never be sold to email marketers.

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