The
US Food and Drug Administration yesterday recommended that patients
with heart defibrillators connected to Riata leads from St Jude Medical
obtain an X-ray or some other diagnostic imaging to check for possible
lead-insulation problems.
St
Jude Medical recalled its Riata and Riata ST leads last December
because premature erosion of their insulation causes malfunctions such
as abnormal sensing or pacing, delivery of inappropriate shocks, or the
failure to deliver a shock at all. Although the company stopped selling
these leads in late 2010, some 79,000 still remained implanted in
patients as of 2011, according to the FDA.
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