• As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

    A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources. St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," repo...
  • Report: New Troubles for Medical Device Manufactuers, FDA After Faulty Leads Lead to Questions

    The medical device industry is being shaken by a series of issues involving St. Jude Medical's defibrillator leads, reports The New York Times , leading to serious questions about transparency, adequate regulation and patient safety. The medical device leads have been implicated in a series of serious adverse events, including some where the wire contained inside the defibrillator leads have failed, leaving the wires to become exposed. The Times reports two other med...
  • Study: Medical Device Safety Could Be Improved With Help of Software

    • 09 March 2012
    A new study published in the American Health Association's journal Circulation: Cardiovascular Quality and Outcomes says that commercially available software could discover problems with medical devices well before traditional adverse event tracking systems are able to, reports Fierce Health IT . The study looked at 2710 implantable cardioverter-defribrillator leads, of which 107 failed during the study. Software used by the study was able to successfully alert the au...