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Reports of St. Jude’s Riata defibrillator leads puncturing holes in patients’ hearts are raising new concerns about the safety of medical heart devices. The reports come just weeks after Medtronic recalled certain models of its Sprint Fidelis leads over their potential to fracture.
PACE Publication
In the most recent issue of the journal of Pacing and Electrophysiology (PACE), four cases of heart perforations caused by St. Jude’s Riata leads are highlighted. One case involves a Riata lead that came within a quarter-inch of penetrating the patient’s skin.
FDA Reports
The Food and Drug Administration database of adverse events contains reports of 15 heart punctures and one death associated with Riata leads. However, cardiologist Stephen Vlay believes these types of incidents may be underreported.
When Leads Fail
A tiny wire component of implantable defibrillator devices, leads are responsible for delivering life-saving shocks when an abnormal heart rhythm is detected. Leads that malfunction or puncture a hole in the heart can have serious, sometimes fatal, effects in patients.
Dr. Vlay is encouraging healthcare professionals to report incidents potentially related to Riata leads, which he says may have “an inherent design flaw.”
(Source: MSNBC news)
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