Archive for the ‘Medtronic’ Category

Heart Doctors report Risks of Defibrillator and Pacemaker Hacking- Possible Compromise of Patient Safety?

Wednesday, March 12th, 2008

In another blow to patient confidence in pacemakers and defibrillators, Keith Weinstein of the WSJ report in Heart-Device Hacking Risks Seen, that physicians studying the vulnerability of pacemakers and defibrillators have demostrated that such devices may be prone to cyber-attacks, or hacks, that could potentially compromise patient privacy, or even worse patient safety. A massive Medtronic defibrillator recall and Boston Scientific / Guidant Pacemaker recall in 2005 has played an impoortant role in raising concerns regarding heart device safety.

According to the report, Physicians use a device called a “Programmer” to communcate with the device wirelessly. The Programmer allows the Dr. to tell the device at what rate to pace a heart, and when to send what should be life saving charges to start a heart that has fallen into a fatal arrythmia.

According to the researchers, computer hackers could transmit the same radio signals used by the programmers to a patient’s device and potentially cause a defibrillator to shock or shut down, or reveal confidential patient data.

The study, urges Medtronic, Boston Scientific, and St. Jude to develop secure methods to “stop unauthorized people from hacking into the implanted medical devices that receive instructions via radio waves, a growing category that also includes spinal-cord stimulators and drug-delivery pumps.”

“This report demonstrates that you can obtain private information without authorization. You can reprogram the device without authorization,” according to William Maisel,from Harvard. Dr. Maisel further stated “our report is a theoretical risk, not an actual risk” and said there was no reason for anybody to consider deferring an implantation or removing a defibrillator.

“I find it absolutely terrifying, the idea of having computer-controlled devices implanted in us,” said Aviel Rubin, a professor of computer science at Johns Hopkins University who wasn’t involved in the research. “If you can imagine what you might do in a very busy area, sending out a signal that would cause all of the people in the local area’s implanted devices to start operating incorrectly, it’s a really scary future we’re headed towards.”

According to the WSJ report, Dr. Maisel and his collaborators — Kevin Fu of the University of Massachusetts, and Tadayoshi Kohno of the University of Washington, both computer-science professors — emphasized that the findings are as yet limited to one model of defibrillator made by Medtronic, the Medtronic Maximo, which was subject to a previous Medtronic recall related to a defective medtronic battery.

Semper Fidelis – Was Medtronic Committed to Patient Safety when they continued to sell now recalled defective Defibrillator lead wires

Wednesday, March 5th, 2008

In today’s New England Journal of Medicine, Dr. William H. Maisel, M.D., M.P.H. , the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston, Massachusetts, published an editorial, entitled Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices examining whether consumers can ever recieve adequate protection for faulty medical devices. Dr. Maisel focused his artcle on the recent debacle over defective Medtronic lead wires for their pacemaker/defibrillator models, otherwised known as Implantable Cardio-Defibrillators, or ICDs. Medtronic, at the behest of the FDA, recalled Medtronic Sprint Fidelis lead wires in October, 2007. But according to the article, Medtronic had alerted some doctors via a cryptic letter in March of 2007 that they were detecting a greater number of reports of lead failure, or lead fracture than expected. And by May, 2007, Medtronic had applied for a manufacturing change for the lead wires to correct the manufacturing defects which were causing the lead wire fractures. But for nearly 6 months, Medtronic sold defective defibrillator lead wires, Sprint Fidelis Lead wires, to unsuspecting patients. As reported in the article, the defective lead wires could contribute to significant medical propblems for these patients, including: a failure to pace, a failure to defibrillate, unnecessary shocks, and death.

According to Maisel’s article,

“by October 2007, Medtronic had confirmed the occurrence of 665 fractures in returned leads, five patient deaths to which a Fidelis lead fracture may have contributed, and a 2.3% fracture rate within 30 months of implantation (according to an analysis of the remote-monitoring data)”

For More information about the Maisel artcile in the NEJM, please visit www.nejm.org, or for more information about the litigation regarding these recalled Medtronic lead wires, please visit our website at www.awkolaw.com or www.awkolaw.com/medical_medtronicnews.html