This week Boston plays host to the ICD Lead Performance Conference. This conference is dedicated to the wires that connect implantable cardioverter defibrillators (ICD) to the heart. These little wires were tossed into the public eye back in October when medical device giant, Medtronic, recalled one of its most popular leads due to an elevated risk of breakage. Reports of the defective wires giving shocks at in appropriate times and failure provide the desired shock to the heart in the time of need prompted the FDA to issue a Class I recall of the leads.
Experts from around the country expressed their concerns about the lack of voluntary reporting of failures by doctors and lab testers. St. Jude Medical representative, Philip Tsung, estimated that as many as 50 percent of all removed leads are sent back to the factory for failure analysis.
Lab tests got criticized, too. Megan Moynahan, chief of the FDA’s defibrillator branch, asked why manufacturers only bend leads a limited number of times, simulating heartbeats, so that “all devices pass all tests.” Why not flex them until they fail, she asked, to separate stronger leads from weaker ones.
It is nice to see the manufacturers addressing the issues with these devices and making an attempt create more awareness and ultimately make a safer product for everyone.
For more information on this subject, please refer to the section on Drugs, medical Devices, and Implants.
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