Medtronics Ensura Diving

Hi, I have a shiny new Medtronics Ensura implant. It's only been in 24 hours but I'm already trying to find depth ratings for it. I'd be very happy to return to a little blue warm water scuba. I've never been much of a depth freak - most of the creatures that I'd like to photograph are near the surface.

4 Comments

Also

by donr - 2011-09-03 09:09:02

Have you ever considered the possibility that a PM could generate electric fields strong enough to attract pelagic sharks? After all, they sense prey by electric fields, especially if the potential prey is injured.

Back in 2006, My whole family went to Hawaii. #2 Daughter arranged for us to go "swimming w/ the dolphins." Now, Hawaii is habitat for several species of pelagic sharks & I called Medtronics to see if they had any data on that subject. They didn't & asked if I'd like to help them collect it - tongue in cheek, I suppose. I obviously didn't att act any.

Didn't even see any, even small ones.

Don

Depth Limitting Factor

by ElectricFrank - 2011-09-04 01:09:06

It isn't the crush resistance of the titanium shell that determines the depth resistance. It is the seal where the lead connectors come through the end of the pacer. I'm looking at my old one that I kept after replacement. There is a fairly large area of plastic with the connectors embedded in it. The recessed openings where the leads connect are designed to mate with some sort of seal on the lead ends. There are warnings in the implant manual about making sure that the leads are totally seated and sealed. I suspect this seal and also where the connections exit the case determine the pressure that can be handled, If a leak occurs at the leads it provides a route for the pacing current to leak and stimulate the surrounding tissue, like giving jumping pects.

frank

Medtronics info

by k6rff - 2011-09-05 09:09:33

Very helpfully, Hugo, our Medtronics rep has given me a their datasheet regarding diving. It is not too good as it only allows diving down to 15metres (although that is better than nothing) and, hey, I'm still able to dive and also have MRI scans. Also this data is 4 years old and may need updating. The Ensura is a newer product.

Now for someone who was having 9 second lapses in the week prior to implantation, I'd say I've not a lot to grumble about. I did ask their longest lapse and they said 11 secs. When I asked what happened at 12 secs they went quiet.

I work in an MRI environment and this will be pretty handy for me. I should point out that these MR pacemakers are conditional rather than compatible - they have to be deactivated prior to entering the magnet bore.

HYPERBARIC CHAMBER TREATMENTS
Rev. A.1, page 1 of 1
PACEMAKER (IPG – IMPLANTABLE PULSE GENERATOR)
DEFIBRILLATOR (ICD – IMPLANTABLE CARDIOVERTER DEFIBRILLATOR)
Medtronic has performed hyperbaric chamber testing on several pacemakers and
defibrillators to determine the maximum safe pressure for hyperbaric chamber therapy. This
testing was performed at selected pressures up to 165 feet of seawater or 6 Atmospheric
Pressure Absolute (ATA). The devices used for this testing included Thera i™, Prodigy™,
and Elite II™. These devices exhibit rate response and were chosen because they are
representative of current models with respect to mechanical susceptibility to external
pressure.
No loss or degradation of output operation was observed in any of the devices tested,
however, rate responsive pacing began to diminish at pressures in excess of 66 feet of
seawater (3 ATA) which caused the devices to pace at the programmed lower rate. The loss
of rate responsive pacing was observed to be temporary; activity pacing returned at lesser
pressures. It was also noted that pressures approaching 132 feet of seawater (5 ATA) began
to significantly deform the titanium shield.
Following the hyperbaric chamber testing, all devices were analyzed for final functional and
activity performance. Each device performed within specification.
In summary, Medtronic devices similar to the Medtronic pacemakers and defibrillators tested
should operate normally up to 49.5 feet of seawater (2.5 ATA), and will begin to
significantly deform at pressures near 132 feet of seawater (5 ATA).
Based on results of this testing, similar Medtronic pacing devices should not be exposed to
pressures in excess of 49.5 feet of seawater (2.5 ATA). It is the responsibility of the
physician to determine the safety concerns for these pacemaker patients and make the final
decision concerning the use of hyperbaric chamber treatments when indicated.
Although we are not aware of any reported incidences of ICD shock triggered ignition, and
do not believe this to be of significant risk, it may be advisable to disable defibrillation
therapies, pending further study to the contrary, while patients are undergoing hyperbaric
treatments. Ensure that an external defibrillator and medical personnel skilled in
cardiopulmonary resuscitation (CPR) are present while device therapies are programmed off
should the patient require external rescue.

Good info

by ElectricFrank - 2011-09-07 01:09:13

This is why Medtronics is my favorite pacer manufacturer. They seem to have a very open open policy and respond with reliable data rather than marketing hype.

As an engineer this gives me a lot of confidence.

frank

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