If you or someone you know has a Boston Scientific pacemaker this communication is important for you

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Boston Scientific has found that in some patients with a particular type of pacemaker, there can be a problem with the function (later in the life - last 4 years) of the pacemaker’s battery. The pacemakers affected were all manufactured before September 2018 and a little over 1 in 10 of those devices may be affected.

Note again, that pacemakers in this group are only susceptible to this malfunction in the last four years of their battery life.

In “at risk devices”, due to a manufacturing glitch prior to September 2018, in those last 4 years’ life of the battery, it is possible for the pacemaker to revert to a very basic pacing function called “safety mode pacing”.

The reason for this is that certain actions, such as interrogation of the pacemaker either by the home monitoring kit or programmers used in the hospital clinic, will put greater strain on the battery. The safety mechanisms in the pacemaker’s computer then interpret this as the pacemaker needing to change its function to provide only basic pacing. This is because it recognises that the battery’s capability is reducing and it wants to minimise the risk of unexpected pacing failure before the pacemaker can be replaced.

However, while safety mode pacing will continue to provide basic pacing treatment for very many days, even when the battery is going flat, safety mode pacing is not as sophisticated as normal pacemaker function. In safety mode pacing there are some circumstances in which pacing can be stopped altogether when external electrical factors (for example: checking - interrogating - the pacemaker, strenuous physical activity causing body muscles to generate internal electrical interference) can cause pacing to briefly stop in a way that cannot happen with normal pacemaker function. Safety mode pacing is only intended to be a bridge to pacemaker replacement. That means individuals who are (or almost are) completely reliant on pacing for a heart rhythm, there are some circumstances in which a pacemaker might for a period of time stop altogether, which could lead to collapse.

It is an easy and quick matter to find out whether your pacemaker is one of those susceptible to this problem by contacting the clinic responsible for your follow-up. We recommend you do this if you have a Boston Scientific pacemaker, but if you want to, you can check it yourself by visiting this website:

BostonScientific.com/lookup.

You will need to enter your language, as well as the model and serial numbers of your device, which can be found on your patient ID card.

Remember, if you have one of the affected pacemakers there is no cause for panic.

Your follow up clinic will be checking this for you anyway whether you contact them or visit this website or not.

Who should have a pacemaker box change because of this problem?

On the one hand there is a natural desire to have something that might develop a fault replaced but on the other, box changes themselves carry an element of risk, particularly of introduction of infection or less commonly damage to the implanted patient leads. These “box change” risks have to be balanced against the risks of pacemaker malfunction and it would be wrong to consider doing a box change in all individuals with these pacemakers.

However, some individuals should consider having their pacemaker replaced as it is arguable that the risk of a “box change” is outweighed by the risks of pacing not working.

Discussions about your management are always the responsibility of the physician responsible for your care, but to give you some guidance:

If you have one of the affected pacemakers

and

If your pacemaker is in the last 4 years of its battery life (which can be determined by a pacemaker check by your follow up clinic)

and

If you are “pacemaker-dependent” (your clinic will know this)

then

there is a strong argument for replacing your pacemaker to prevent the risk of pacing failure (i.e. prophylactic replacement).

OR

If you have one of the affected pacemakers

and

If your device has already gone in to safety mode pacing mode and is therefore not providing optimal pacing for your condition

then

there is a very strong argument for replacing your pacemaker to provide optimal therapy.

OR

If you have one of the affected pacemakers

and

If your pacemaker is in the last 4 years of its battery life (which can be determined by a pacemaker check by your follow up clinic)

and

If your clinic for some particular reason (other than being pacing-dependent) considers you to be at high risk of a problem should your pacemaker go into safety pacing mode

then

there is an argument for replacing your pacemaker to prevent the risk of pacing failure (i.e. prophylactic replacement).

Remember, in those individuals who are not pacing dependent the short-term consequences of being in safety pacing mode are minimal and will not cause lasting damage and your pacemaker will be scheduled for replacement as soon the change is recognised by remote or other follow up. Many patients will never go into the patient safety mode.

Medical Executive Committee

ARRHYTHMIA ALLIANCE \ STARS