14 June 2012
The US press
has reported concerns relating to the heart defibrillator lead, the “Durata”, manufactured by St Jude Medical Inc. The Food and Drug Administration’s safety website, MAUDE has published an adverse event report
concerning a potential defect with a “Durata” lead. According to reports, a fluoroscopy revealed protruding cables, a problem detected in earlier leads made by the manufacturer.
The “Durata” is an implantable cardioverter defibrillator (ICD) lead, which works in conjunction with a heart device, as treatment for patients with heart problems. The ICD lead transmits electricity to the heart from the device, designed to deliver a life-saving shock when a dangerous cardiac rhythm is detected. The “Durata” lead replaced the previously recalled and discontinued “Riata” lead, also manufactured by St Jude Medical Inc. who faced criticism following the removal of the device from the market in December 2010.
The failure of the “Riata” lead was considered to be an insulation defect, causing early lead abrasion which allowed the cable conductor to exit the lead body. The “Riata” defect was well publicised as being “time-dependent”, prompting suggestions today that the current case of externalisation of the “Durata” will receive even closer scrutiny as time goes on.
St Jude Medical Inc. is defending any suggestion of a defect in the “Durata” with a spokesperson confirming that no cases of externalised wires on a “Durata” lead had been reported to them.
The medical devices
team at Leigh Day has extensive and significant experience in securing substantial amounts of compensation for people who have suffered health problems or revision surgery after being fitted with medical devices, including hip
and knee replacements. The firm’s claimant product liability
lawyers have been consistently ranked as the UK’s leading firm of defective product specialists by the Legal 500 and Chambers guide to the legal profession for many years. To speak to a member of the team please contact product liability partner Jill Paterson
on 020 7650 1219
or email her here
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