Injuries from implantable heart devices
more from blah
Oct 16, 07

There's been a flurry of news about Medtronic's implantable heart devices. Apparently there are some serious problems, and not just with the devices themselves. The oversight, regulation, testing, and overall necessity of an ICD does not appear to attract as much attention as it should.

We talked to a cardiologist about this stuff and he told us about a patient with an ICD that fritzed out and shocked him 50 times before the battery finally died and it couldn't shock him anymore. As a result of the impromptu Medtronic-induced shock therapy, the man was so upset and freaked out that he spent one month in a psychiatric ward.

I found another article in The New York Times explaining that a woman in Palo Alto had 25 shocks in a one hour period before it stopped (not sure if the battery died on hers or not). She opted to remove the ICD altogether, only to have her doctor recommend a replacement a few months later.... with the exact same thing.

Last year, there were 296 patient reported injuries in 2006. During the same period in 2007, there have been 1,194 reported injuries. It's possible that the overall number of ICD patients increased but the rate of injuries stayed the same. Of course, it's also possible that the number of patients was similar and the failure rates increased, but I doubt it.

Medtronic heart device injuries up in 2007