16 December 2010
The Medicines and Healthcare Products Regulation Authority (MHRA) has today issued an urgent medical device alert in relation to all models of the Riata and Riata ST Implantable cardioverter defibrillator (ICD) leads, manufactured by St Jude Medical. These ICD leads work in conjunction with pacemakers for patients with heart problems.
The MHRA has received 39 confirmed adverse events regarding Riata and Riata ST ICD lead model numbers: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592, 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042.
The reported incidents include patients experiencing inappropriate electric shocks, oversensing caused by noise on the lead, charges in impedance and pacing thresholds and loss of sensing resulting in non-detection of arrhythmia.
The Riata and Riata ST leads were first introduced on to the market in 2002 and it is estimated that around 4,500 of these devices have been distributed around the UK. The manufacturer of these ICD leads, St Jude Medical, have told the MHRA that they plan to stop the supply of these products by 31 December 2010.
Patients concerned about their defibrillator/ pacemaker leads should contact their doctors as soon as possible.
Leigh Day & Co currently represent a number of individuals who experienced problems following their implantation of various Sprint Fidelis ICD leads.
Leigh Day & Co’s product liability team has unrivalled experience in dealing with defective medical device claims. The team is ranked as the number one law firm in the field of product liability by legal directories Chambers and the Legal 500.
If you are concerned that you or a member of your family may have been affected by a Riata or Riata ST ICD lead, and you would like to talk to one of our solicitors about a potential claim, please contact Jill Paterson on 0207 650 1219.
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