After the Guidant fiasco this summer, makers of defibrillators are under pressure to disclose any possible defect in their implants. You might say they’re “subject to penetrating scrutiny” … or “the heat is on” … or “radiation from outer space is draining their batteries”:
“As you may be aware, background cosmic radiation bombards the Earth constantly,” reads St. Jude’s letter dated Oct. 6. “While the Earth’s atmosphere acts as a shield and absorbs much of the cosmic radiation, some amount of high-energy particles do arrive at the Earth’s surface.”
Apparently, those rays can cause a memory chip to drain the battery, sapping the devices’ ability to shock the heart, according to the letter. St. Jude, the smallest of the three players in the ICD market, was able to mimic the effect in a nuclear laboratory, prompting the advisory to doctors and US regulators.
No deaths or serious injuries have been linked to the flaw in the Photon DR, Photon Micro and Atlas VR/DR defibrillators, which are used to correct irregular heart rhythms, according to St. Jude. What’s more, the incident rate is very low. Testing showed that perhaps 60 devices out of 36,000 might be affected, the company said.
We’d venture to guess that frequent fliers will be at greater risk. But it’s worth re-iterating this point: cosmic ray exposure isn’t always a bad thing.
Flashback: Medgadget Archives on Guidant
St. Jude Medical press releases page…
(hat tip: KidneyNotes)