A software monitoring program that tracks implantable cardioverter-defibrillator (ICD) function could detect problems with the devices earlier than current monitoring processes. ICDs monitor heart rhythms and deliver electric shocks to restore normal rhythm when life-threatening, irregular heartbeats occur. But they can malfunction, particularly in the wires that connect them to the heart. “Current monitoring approaches … rely largely on voluntary reporting of adverse events by manufacturers, possibly leading to missed warning signs and ... late recalls,” said Robert G. Hauser, lead study author. Hauser and colleagues used a commercially available software surveillance program to compare data from 1,000 patients with recalled leads to 1,600 patients implanted with ICD leads still on the market. Using the surveillance software, researchers simulated what occurred years earlier. The software detected problems with the recalled leads at least a year before the company had recalled them.
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