Medtronic not certifying some leads for MRI
- by vitdoc
- 2017-10-18 18:44:04
- General Posting
- 1463 views
- 5 comments
I have a Medtronic biventricular pacer for complete heart block. I will be replacing it shortly with a new pacer due to low battery life. Two of my leads are MRI certified but the left ventricular lead has not been certified. Apparently Medtronic decided it was not worth it to certify these leads since only 10,000 were implanted and the lead was discontinued about a year or so ago. So even with a new MRI capable pacer without all the leads certified the system is not considered MRI compliant. I have tried to have Medtronic re visit their decision not to spend the money to go through the certification process. So far they have blown me off. So buyer beware! You would think they should support their products as long as they are still being used. Having the leads certified (assuming they can be certified) should be part of Medtronic’s support. Especially if you go to their website and see how much they talk up the value of MRIs.
If anyone else has this issue with Medtronic please contact them and talk to your physician also.
5 Comments
MRI
by vitdoc - 2017-10-19 00:41:27
Those of you that are having MRI studies probably have MRI compliant pacers and leads. If not, many MRI centers will not do an MRI. That is why it is important for the manufacturer to certify both the pacer and leads.
mri
by Tracey_E - 2017-10-19 09:28:17
Some facilities won't do it even if your device is mri compliant. More and more facilities are starting to do it even if it is not mri compliant, as long as the whole system is less than 10 years old and there are no old leads capped off. It's been common in Europe and is getting more so in the US. It may take some research to find a place willing to do it and you'll have to decide if you need it badly enough to travel, but they are out there.
Difficulties with MRI scans
by LondonAndy - 2017-10-19 09:34:37
TraceyE is right - here in the UK it has taken me 2.5 years to have this scan done, though reluctance to do a scan of someone with a cardiac device (ie a pacemaker or CRT-D) has been only part of that, and administrative incompetence/resource issues with our NHS have been responsible too. In fact at the MRI unit at Barts hospital today, a doctor interviewed me about my delays, and says that his goal is to "promote MRI for those patients with cardiac devices" given that demand is increasing and technology has reached a point where risks are much reduced compared with the past.
I will post separately about this shortly, in case others in the UK are having problems getting a scan done.
Incidentally, this doctor singled out Medtronic for praise in respect of their research and development of MRI compatible devices.
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MRI tomorrow!
by LondonAndy - 2017-10-18 21:43:26
Thanks for the alert. I have a Medtronic Ensura DR MRI dual chamber device, and am due to have an MRI tomorrow, so doubtless will find out if any problem getting it done ....