SCS Anchor

Who has the best anchor on the market?

Does Nuvectra still have only that anchor with metal insert that you have to crush down? Looks like they are working on new design according to US20180099147A1 (https://patents.google.com/patent/US20180099147A1/...)

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Man, hard to say. As everyone knows, anchors move market share more than any other factor, so the competition is fierce! I’ve heard Nevro is about to publish five year RCT data on an anchor developed in secret. It’s known as Project Ramihook, and it’s gonna be a game changer!!!

LOL!!!

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This ignores the obvious... another company's anchor was used in conjunction with Nuvectra lead... Regardless, one incident is not a trend.

There are four reported fractured/broken anchors from 2018. Usually if a failure is due to another company's product, it says that in the MAUDE entry in the manufacturer's narrative section. There is no manufacturer's investigation comments in any of these four which is unusual.


2018/03/14 Event Description: IT WAS REPORTED TO NUVECTRA THAT THE STIMULATOR AND LEAD WERE EXPLANTED DUE TO THE PATIENT EXPERIENCING A LACK OF THERAPEUTIC EFFECT FOLLOWING 15 MONTHS POST PERMANENT IMPLANT. DURING SURGERY, UPON OPENING THE INCISION, THE ANCHORS WERE BROKEN. ALL THE PIECES WERE REMOVED AND THE PATIENT IS DOING WELL.

2018/05/10 Event Description: IT WAS REPORTED TO NUVECTRA A REVISION OF THE STIMULATOR WAS PERFORMED DUE TO HIGH IMPEDANCE READINGS. DURING THE REVISION SURGERY, THE PHYSICIAN NOTICED A FRACTURED LEAD THAT WAS CAUSED BY A BROKEN ANCHOR. SUBSEQUENTLY, THE STIMULATOR AND LEAD WERE REPLACED.

2018/08/06 Event Description: IT WAS REPORTED TO NUVECTRA THAT A REVISION WAS PERFORMED DUE TO A LEAD MIGRATION. DURING THE SURGERY, THE PHYSICIAN NOTICED A FRACTURED ANCHOR. SUBSEQUENTLY, THE LEAD AND ANCHOR WERE REPLACED.

2018/10/10 Event Description: IT WAS REPORTED TO NUVECTRA THAT A REVISION WAS PERFORMED DUE TO A LEAD MIGRATION. DURING THE SURGERY, THE PHYSICIAN NOTICED THE FRACTURED ANCHORS. SUBSEQUENTLY, THE LEADS AND ANCHORS WERE REPLACED AND THE PATIENT IS DOING WELL.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs...

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs...

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs...

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs...

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On 03/14/2018 they had an adverse event where a patient couldn't get therapy and when they opened the patient up "THE ANCHORS WERE BROKEN. ALL THE PIECES WERE REMOVED." I don't see how the old 5400 anchor could break into pieces. They must have a new one.

Event 3010309840-2018-00078

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs...

This ignores the obvious... another company's anchor was used in conjunction with Nuvectra lead... Regardless, one incident is not a trend.

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On 03/14/2018 they had an adverse event where a patient couldn't get therapy and when they opened the patient up "THE ANCHORS WERE BROKEN. ALL THE PIECES WERE REMOVED." I don't see how the old 5400 anchor could break into pieces. They must have a new one.

Event 3010309840-2018-00078

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs...

Thanks. Really important work your doing here. Impressive.

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On 03/14/2018 they had an adverse event where a patient couldn't get therapy and when they opened the patient up "THE ANCHORS WERE BROKEN. ALL THE PIECES WERE REMOVED." I don't see how the old 5400 anchor could break into pieces. They must have a new one.

Event 3010309840-2018-00078

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs...

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Man, hard to say. As everyone knows, anchors move market share more than any other factor, so the competition is fierce! I’ve heard Nevro is about to publish five year RCT data on an anchor developed in secret. It’s known as Project Ramihook, and it’s gonna be a game changer!!!

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