UK Calls for a Close Watch on Riata Patients
Published date : 20 September 2012
Article date : 20 September 2012
Massdevice reports that UK health and regulatory agencies have been keeping a close eye on St. Jude and its Riata leads since late last year, when the company had to remove the devices from the US following an FDA Class I recall directive. Apparently, reports showed that the devices may be prone to internal short circuits that were more rare than the incidence of exposed wires but potentially more dangerous.
St. Jude also pulled its QuickSite and QuickFlex left-ventricular leads in the US after finding 39 confirmed cases of exposed wires.
Apparently, the UK's alert calls for physicians to keep a close watch on Riata patients, conduct regular testing to determine the integrity of the leads and consult with patients about whether or not to replace defective wires or take a proactive approach against intact leads, perhaps during a defibrillator box replacement procedure.
The MHRA urged physicians to make sure that, should a patient decide to keep Riata or Riata ST leads at the time of box replacement, that any future devices contain remote/advanced monitoring capabilities.
Source: Massdevice, 17 September 2012
Read the full article here.
