In case you missed it, with all the hullabaloo about breast implants, UK MHRA issued it’s own Alert just before Christmas to roughly coincide with FDA’s statement that St Jude Medical’s Riata implantable defibrillator voluntary recall is being considered as more than voluntary now. While in USA it’s a Class 1 recall as we reported here, in UK it’s subject to a Medical Device Alert (MDA) issued by MHRA.
St Jude’s Riata and Riata ST implantable defibrillators have been widely reported to suffer undue “externalisation” with the attendant risk of delivering electrical energy inappropriately. While clinicians are not being advised to remove wires prophylactically they are being advised to monitor patients closely and resort to fluoroscopic evaluation or ultimate removal should concerns arise. Furthermore a product recall is underway.
In USA last week an expert group including clinicians and senior St Jude representatives met to discuss management of the problem, as we reported here yesterday.
The full MDA can be found here.