Documentation of Medtronic ERI program changes

I was advised that Medtronic has changed the new devices so that they do not revert to 100% Ventricular pacing "only" (VVI) before replacement is permitted by  insurance. However, I have not been able to locate documentation that directly reflects this in a clear and concise statement. Although. I did find the following information that I believe pretty clearly documents it. I hope that someone smarter than me can help and comment on this. It is obviously very important to us that have suffered through the automatic ERI programming changes in the past.

Here is what I found:

Older PM's (like the one that I have) have a combined Recommended Replacement Time (RRT) and Elective Replacement Indicator (ERI) So in essence the recommended replacement time and ERI happened at the same time.

So here is what seems to have changed in the new devices:

The RRT is now 3 months "before" ERI (it is determined by battery voltage of 2.63 or less on 3 consecutive daily automatic measurements). 

ERI is now 3 months "after" RRT 

Then you have EOS (end of service) 3 months after that

However, I am unsure exactly what happens at ERI in these new PM's. However, I suppose that it may be irrelevant if you have three months prior to that in which to get a replacement. I don't think insurance can object to getting a replacement if the manufacturer recommends it. I think that additional good news is that we now have a 9 month buffer before the battery dies.

Now, this was the best I could come up with, but it sure seems like it is an accurate reflection of the change. I really would like to have a doctor or someone from Metronic or someone smarter than me confirm all of this. I will do that when I have the opportunity. I guess that I am concerned that I could have it wrong and I certainly do not want to misinform anyone. Obviously, if we now look to "RRT" for the time when we can have a replacement, that is a significant meaningful change. So hopefully; someone else can follow-up on this effort and let us know what they come up with.

Sincerely,

Dave

 

5 Comments

Reassuring News - Thanks Dave

by SeenBetterDays - 2024-02-10 10:31:57

Hi Dave

Thanks for taking the time to look into this and post your findings.  I am really glad that manufacturers have potentially taken on board the need for an early indicator on the devices which gives an additional cushion of time before there is a change in pacemaker functionality.  It just doesn't seem right that some pacemaker recipients, as recently documented by a club member, have been forced to endure this horrible period of struggling through at minimum pacing prior to replacement surgery.  Anything which changes the position on this has to be a good thing.  Great news, thanks Dave!

Rebecca

What my Medtronic Ensura manual states

by Gemita - 2024-02-10 11:51:05

6.7.1.2 Battery voltage and replacement indicators 

The most recent automatic daily battery voltage measurement is displayed on the Battery and Lead Measurements screen. 

If 3 consecutive automatic daily battery voltage measurements are less than or equal to the Recommended Replacement Time (RRT) value, the programmer displays the RRT symbol and the date when the battery reached RRT. If the programmer displays the RRT symbol, contact your Medtronic representative and schedule an appointment to replace the device. 

The expected service life of the device after RRT, defined as the Prolonged Service Period (PSP), is 6 months (180 days). After the first 90 days of the PSP have passed, the device reaches the Elective Replacement Indicator (ERI) and the programmer displays the ERI symbol.  When the device reaches ERI, it automatically changes the pacing mode to VVI and sets the pacing rate to 65 bpm. It also changes the value of several other programmed parameters. See Section A.3, “Replacement indicators”, page 252 for more information about the Ensura DR MRI device and see Section B.3, “Replacement indicators”, page 263 for more information about the Ensura SR MRI device. After the 180-day PSP has expired, the device reaches End of Service (EOS), and the programmer displays the EOS symbol. 

Warning: Replace the device immediately if the programmer displays an EOS indicator. The device may lose the ability to pace and sense adequately after the EOS indicator appears. 

Note: After ERI, all pacing parameters can be programmed, including mode and rate. Reprogramming the pacing parameters may reduce the duration of the ERI to EOS period. 

When the battery voltage reaches the RRT value, the Battery and Lead Measurements screen displays “Replace Device” instead of an estimate of remaining longevity. When scheduling the replacement of the device, do not use the estimate of remaining longevity. Instead, schedule the device replacement after the RRT condition is reached.

Dave, when I can I will ask my clinic to confirm their policy and then either add to this post, or do another post.  I have yet to experience a device change and don't look forward to a different mode from AAI or to a slower base rate, so I hope they will change my device long before it starts cutting back!

Update.  Recommended Replacement Time =  ≤ 2.83 V on 3 consecutive daily automatic measurements

Gemita, Thank you!

by Good Dog - 2024-02-10 12:19:50

That is the confirmation that I was looking for. I am not sure why the discrepancy  between 2.63 and 2.83. It could be that different models have different spec's, but I guess that in actuality it really makes little difference. I still have an old (Adapta) device from 2015 and that relies on ERI for replacement. It seems pretty clear now that based upon what you read in your manual and what I read on the new Azure dual chamber documentation page; that they have in-fact eliminated the need to wait for ERI to replace. In-fact, they are now saying DO NOT WAIT. That is GREAT NEWS!!!

I find it interesting that they never announced that change???

Thanks so much for your help with this!

Sincerely,

Dave

eliminate ERI - Yes!

by natalie - 2024-02-13 19:00:35

Thank you all for talking about the change to  "eliminate the need to wait for ERI to replace and clearly noting DO NOT WAIT."  I've added this in my notes for this experience., just to be sure.

ERI for 12 days was a nightmare.  For anyone who is stuck in this old system and have these same symptoms, please get help.   

It's day 5 post op and I'm feeling so great.  It's a 100% change from ERI to new pacemaker.  I'm grateful for all of you!

 

This is how Boston Scientific is

by PacedNRunning - 2024-02-24 01:52:58

This is the way Boston Scientific devices work.

ERI/RRT is the elective replacement indicator. You programming stays the same for 90 days. You have 90 days to change out the battery.

At EOL, it changes to 50 bpm VVI.  

 

 

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